Palo Alto Health Sciences Obtains FDA-Clearance for Freespira in Treating Post-Traumatic Stress Disorder

Ninety-one percent of PTSD patients had significant reduction in PTSD Assessment Score and 50% of patients no longer met diagnostic criteria for PTSD six months post
Freespira treatment

Kirkland, WA (December 18, 2018) – Palo Alto Health Sciences, Inc. (PAHS) announced today that its flagship digital therapeutic, Freespira®, has been cleared by the FDA as a treatment option for patients diagnosed with post-traumatic stress disorder (PTSD).

PTSD is serious and devastating, occurring after a traumatic event such as combat, an accident, a violent personal assault or a physical trauma such as an explosion. Annually, close to eight million adults are diagnosed with PTSD and it is estimated that 7-8% percent of the US population will experience PTSD in their lifetime. Sixty-seven percent of those exposed to mass violence have been shown to develop PTSD symptoms.

A clinical trial was conducted at the Veterans Administration Palo Alto Health Care System to demonstrate the efficacy of Freespira for veterans and non-veterans suffering from PTSD.  The primary endpoint of this study was to determine if treatment with Freespira could reduce the patient’s CAPS-5 score.  CAPS-5 is a standardized in-person validated clinical assessment tool for measuring the severity of PTSD.[1]   Response was defined as a reduction of six or more points. Remission was defined as response plus no longer meeting clinical symptom criteria and having a CAPS-5 score < 25.

The study met its primary endpoint with a large majority of subjects achieving the specified 6-point reduction in the CAPS-5 score at two months and six-months post-treatment (93% and 91% respectively).   Importantly, 86% of patients had a 13-point reduction in the CAPS-5 score at 6 months.  In addition, 50% of the patients no longer met the diagnostic criteria for PTSD, thus providing them with a sustained remission of their PTSD until at least six months post-treatment.  Patient satisfaction was 90% at six months post-treatment. Furthermore, mean patient adherence to the treatment protocol was 77%. Based on these results, FDA-cleared Freespira to treat PTSD.

The most common treatments for PTSD are exposure-based psychotherapeutic methods and/or medication, both of which have significant limitations. Medications have adverse effects and limited efficacy, and are no longer recommended in the VA/DOD Clinical Practice Guidelines for Management of PTSD as a first line treatment. In contrast with exposure-based treatments,  treatment with Freespira allows patients to avoid the revisiting of traumatic memories common in treatment with exposure therapy while at the same time decreasing the need for highly trained specialists and a long-term time investment to deliver this type of therapy.

“PTSD is extremely difficult to treat. The availability of an effective, four-week, drug-free intervention is a game changer for people suffering from PTSD. Freespira offers hope for people who otherwise experience a significantly diminished quality of life,” said principal investigator Michael Ostacher, MD, MPH, MMSc, Staff Psychiatrist at the VA Palo Alto and Associate Professor of Psychiatry and Behavioral Sciences at the Stanford University School of Medicine.

 

About Freespira®
Freespira is an FDA-cleared, drug-free, treatment for PTSD, panic disorder, panic attacks and other panic symptoms. Treatment entails two 17-minute in home sessions daily for four weeks and is authorized and completed under the supervision of a licensed healthcare provider. Freespira is clinically proven to reduce or eliminate panic attacks and other symptoms of panic disorder, and significantly reduce the symptoms of PTSD.  Freespira corrects the abnormal respiratory patterns associated with these conditions by training the user to stabilize and normalize their breathing rate and exhaled CO2 levels.

About Palo Alto Health Sciences, Inc.
Palo Alto Health Sciences, Inc. is a privately held digital therapeutic company revolutionizing behavioral healthcare with evidence-based, non-invasive, drug-free solutions to treat mental health conditions. Their first product, Freespira, is an FDA-cleared treatment for individuals suffering from panic disorder, panic attacks and other symptoms of panic. In the United States, over 6.7 million adults annually suffer from panic disorder; panic attacks affect a total of 27 million adults in the U.S. every year and are a common component of other anxiety disorders.  The latest FDA-clearance for PTSD allows Freespira to be marketed to treat this debilitating condition, which impacts about 8 million Americans annually.

Freespira is currently commercially available for panic throughout the U.S. and will be available for PTSD in the second half of 2019.

  1. Weathers, F.W., Blake, D.D., Schnurr, P.P., Kaloupek, D.G., Marx, B.P., & Keane, T.M. (2013). The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www.ptsd.va.gov.

Highmark Inc. Adds Coverage For Medical Innovations In Treatment Of Panic Attacks […]

PITTSBURGH, Pa. (Sept. 17, 2018) — A new, non-pharmaceutical treatment, Freespira, and non-invasive diagnostic technology, Heartflow FFRct (fractional flow reserve), were added to Highmark’s medical policy in 2018 following positive results from a program that fast-tracks medical innovations to the marketplace.

Freespira, an in-home digital therapeutic device for panic disorder and panic attacks occurring with other anxiety conditions, was added to Highmark’s medical policy in May 2018 and now covers the treatment option for members.

Panic attacks are primarily associated with anxiety disorders such as generalized anxiety disorder, post-traumatic stress disorder, and social anxiety. Symptoms associated with panic attacks are often misinterpreted by patients as a serious medical event such as heart attack or stroke, leading to over-utilization of medical services, such as emergency room visits, diagnostic testing, medications, primary, and behavioral health provider visits.

“Anyone suffering from anxiety or panic attack has their own unique fears,” said JamieLee Kwolek, a Highmark member. “A fear of mine was relying on medication for a condition that I wanted to learn how to treat and manage holistically. I felt like I had missed so much of my life trying to determine how to cope with this diagnosis, and I was afraid that my options were limited to medications that might disrupt my life even more. Freespira gave me the tools I needed to truly understand and use the option I had all along — my breathing. I am so grateful to have found a holistic, sustainable treatment that truly gives me control and understanding over my anxiety and panic attacks.”

Results of a Highmark Health VITAL Innovation Program study showed that after just 4-weeks of using Freespira, more than 80 percent of the participants treated were panic attack free. Moreover, 80 percent were panic attack free and 93 percent reported overall panic symptom reduction at 12 months post-treatment.

“Freespira has shown very promising results as a viable, non-pharmaceutical option for our members,” said Charles DeShazer, M.D., chief medical officer, Highmark Inc. “Our policies undergo a rigorous standard of review and evaluation to ensure that our members are covered for proven technology and treatments that are aligned with our value-based reimbursement model of care. Freespira has successfully demonstrated that it provides sustainable, positive outcomes for our members while driving down costs associated with over-utilization of medical services, making this new policy a ‘win-win’ for members, providers, and insurers.”

Also added to Highmark’s medical policy in 2018 was HeartFlow, a novel non-invasive diagnostic technology that offers physicians insight into both the extent of a patient’s coronary arterial blockage and the impact the blockage has on blood flow.

Traditionally, diagnostic options for coronary artery disease included either a non-invasive stress test or an invasive heart catheterization. Heartflow is the first non-invasive technology to combine the information provided by a heart catheterization and stress test, which can reduce the need for invasive testing and aid physicians in their diagnostics and improve treatment strategy.

Both technologies were evaluated through Highmark Health’s VITAL Innovation Program, a test-and-learn platform for early-stage health innovations that produces evidence in patient experience, care, and cost outcomes that may accelerate coverage by health plans and care delivery systems.

The VITAL program provides an additional layer to Highmark Inc.’s policy review, enabling a greater understanding of the full impact of new technologies on members without changing insurance medical policy prematurely. Once a study is completed, Highmark Inc. evaluates the results as part of an extensive medical policy review process to determine coverage for the treatment or diagnostic tool.

Other “VITAL-graduated” programs which resulted in medical policy changes within the past year were LINX, a non-invasive treatment to help manage symptoms and risks for patients with acid reflux, and Bronchial Thermoplasty, a non-pharmaceutical option for managing the symptoms of asthma.

ABOUT HIGHMARK INC.

Highmark Inc. and its health insurance subsidiaries and affiliates collectively are one of America’s largest health insurance organizations and together with its Blue-branded affiliates, collectively comprise the third-largest overall Blue Cross and Blue Shield-affiliated organization in the country based on capital. Highmark Inc. and its affiliates operate health insurance plans in Pennsylvania, Delaware and West Virginia that serve approximately 4.6 million members and hundreds of thousands of additional individuals through the BlueCard® program. Its diversified businesses serve group customer and individual needs across the United States through dental insurance, vision care and other related businesses. Highmark Inc. is an independent licensee of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield companies. For more information, visit www.highmark.com.

For more information, contact:
Leilyn Perri
Highmark Health
717-302-4243
leilyn.perri@highmarkhealth.org

Multiple Studies Show Freespira® Eliminates Panic Attacks in 80% of Patients

50% Reduction in Health Costs One Year Post-Treatment Also Demonstrated

Danville, CA – (April 11 , 2018) – Palo Alto Health Sciences, Inc. (PAHS), developer of the drug-free Freespira® treatment for panic attacks and other symptoms of panic disorder, today announced that another study has demonstrated clinically significant symptom improvement, with 80% of patients panic attack free one year after treatment.

This latest study, conducted as part of the VITAL Program at Allegheny Health Network in Pennsylvania, also demonstrated a 50% reduction in healthcare costs in patients with panic symptoms 12 months after being treated with Freespira.

A Symposium at the Anxiety and Depression Association of America (ADAA) Annual Conference in Washington, DC focused on the impact of abnormal breathing patterns on anxiety-related conditions and treatments as reported in five studies. Two studies reported nearly 80% of Freespira-treated patients were panic attack free at 12 months post-treatment. Two additional studies reported that patients with mixed anxiety disorders and low exhaled CO2 at baseline were less responsive and/or discontinued treatment with Cognitive Behavioral Therapy or Acceptance Commitment Therapy.

Early data from a fifth study reported on Freespira treatment for patients with Post-Traumatic Stress Disorder (PTSD). Ninety percent of patients in this study experienced a significant improvement in PTSD symptoms at two months and six months post-treatment.
Symposium Chair David Tolin, Ph.D., Director of Anxiety Disorders Center, The Institute of Living, and Adjunct Professor of Psychiatry, Yale University School of Medicine, commented, “Studies of the Freespira treatment have shown that this innovative approach to treating patients suffering from panic symptoms and panic attacks not only significantly reduces or eliminates these symptoms in approximately 80% of patients, but also results in meaningful reduction in health costs.”

Debra Reisenthel, CEO of Palo Alto Health Sciences, added, “Patients with panic symptoms and panic attacks have 3-5 times higher medical costs than patients without panic due to higher utilization of medical resources, including ED visits, physician visits and prescription drugs”.
Freespira is both easy to use and effective. Once a licensed healthcare provider authorizes the treatment and after a single training session, the patient uses Freespira at home, performing two 17-minute breathing sessions a day over a four-week period, after which the treatment is complete. The peer-reviewed published multi-center Freespira clinical trial, presented by Dr. Tolin, demonstrated that 71% of patients were panic attack free immediately after treatment and 79% of patients were panic attack free 12 months post-treatment.

About Freespira
Freespira is an FDA-cleared, drug-free, four-week at-home treatment for panic attacks and other panic symptoms. Treatment is authorized and completed under the supervision of a licensed healthcare provider. Freespira is clinically proven to reduce or eliminate panic attacks and other symptoms of panic disorder, a mental health condition in which debilitating anxiety leads to life-altering avoidance behaviors. Individuals with panic chronically hyperventilate, even when not experiencing a panic attack. This abnormal breathing pattern has been shown to exacerbate attacks. Freespira works by training the patient to stabilize respiration rate and exhaled carbon dioxide levels, which reduces or eliminates panic attacks.

About Palo Alto Health Sciences, Inc.
Palo Alto Health Sciences, Inc. is a privately held digital therapeutic company revolutionizing behavioral healthcare with evidence-based, non-invasive, drug-free solutions. Their first product, Freespira, is an FDA-cleared treatment for individuals suffering from panic disorder, panic attacks and other symptoms of panic. In the United States, over 6.7 million adults annually suffer from panic disorder; panic attacks affect a total of 27 million adults in the U.S. every year and are a common component of other anxiety disorders.

Palo Alto Health Sciences Accelerates Commercialization of Freespira®

Palo Alto Health Sciences Accelerates Commercialization of Freespira®

Company is expanding focus on bridging mental and physical health in employer and payer-covered care delivery models – expands leadership team

Danville, CA – March 14, 2018 – Palo Alto Health Sciences, Inc. (PAHS), the manufacturer of Freespira®, the only FDA-cleared digital therapeutic solution for treating panic attacks associated with multiple behavioral health and medical conditions, announced that is has accelerated its commercialization strategy.  PAHS has expanded its leadership team and reports additional results validating the clinical outcomes quantifying the cost-benefits of Freespira from a multi-year study with Highmark Health.

A key component of PAHS’ commercialization strategy is the expansion of its leadership team with two key hires that have a combined 50+ years of healthcare leadership experience with Payers (Cigna, Anthem/WellPoint) and successful health technology companies to help lead the company through its next stage of growth.  Nancy Powers, Chief Growth Officer, is the former Senior Vice President GPS strategy at NantHealth LLC, Senior Vice President Global Business Development Best Doctors and Co-Founder, CorSolutions.   In addition, Rochelle Porper, Vice President of Business Development, joined the team.  Her experience includes former Vice President of Sales at Best Doctors, Health Management Corporation/Anthem, and CorSolutions.

“Panic is comorbid with, and complicates, many chronic conditions – worsening overall health symptoms, increasing medical spending and decreasing quality-of-life.  Multiple studies validate that conditions like depression, diabetes, IBS, migraines, insomnia and more are exacerbated by panic,” said Nancy Powers, Chief Growth Officer.  “Integration of Freespira as an adjunct treatment of these underlying conditions is key to providing value to health plans and employers.”

PAHS has developed an effective treatment for panic that supports risk-based management models, such as ACOs.

Research has shown that individuals with panic (a behavioral health condition) have a physiologic component of their condition; dysfunctional breathing patterns, including chronic hyperventilation.  This leads to lower than normal exhaled carbon dioxide (CO2) levels and symptoms like rapid heartbeat, dizziness and numbness that often mimic major health events.  Individuals with panic interpret these physiological symptoms as a serious medical condition and overutilize medical resources, increasing healthcare costs.

“The results from the Highmark Health/Allegheny Health Network Quality Improvement Program validated that Freespira decreases ER, pharmaceutical and total medical costs by eliminating or reducing panic symptoms. These important findings are directly aligned with the risk-based metrics utilized in ACOs,” said Debra Reisenthel, CEO PAHS.

Freespira is commercially available in the U.S. and is an FDA-cleared, drug-free, 4-week treatment for panic attacks and other panic symptoms associated with anxiety disorders. Treatment is authorized by a licensed healthcare provider and is clinically proven to reduce or eliminate panic attacks, a serious health condition which commonly leads to life-altering avoidance behaviors. Individuals with panic chronically hyperventilate, even when not experiencing a panic attack. This abnormal breathing pattern has been shown to exacerbate panic attacks and increase susceptibility to panic symptoms. Freespira uses a custom sensor and twice-daily at-home protocol to train patients to stabilize their respiration rate and exhaled CO2 levels in four weeks.

About Palo Alto Health Sciences and Freespira®

Palo Alto Health Sciences, Inc. is a privately held digital therapeutic company at the forefront of revolutionizing healthcare with FDA-cleared, evidence-based, at-home and drug-free solutions. Freespira®, is an FDA-cleared solution for individuals suffering from panic disorder, panic attacks and other symptoms of panic.

Highmark Health’s VITAL Innovation Program Validates Effective Drug-Free Treatment for Panic Attacks

Highmark Health’s VITAL Innovation Program Validates Effective Drug-Free Treatment for Panic Attacks

At 12 months post-treatment, participants’ total medical costs reduced by 50%, ER costs by 64%, and medication costs by 53%

Pittsburgh PA and Danville CA – November 28, 2017 — Highmark Health, Allegheny Health Network and Palo Alto Health Sciences, manufacturer of Freespira, today announced the results of a pilot program completed through Highmark Health’s VITAL Program.

In an effort to help health plan members who suffer from panic disorder (PD) and panic attacks, the goal was to demonstrate that once panic attacks were reduced or eliminated, utilization of medical services and the associated costs would be reduced. Results showed that after just 4-weeks of using Freespira®, more than eighty percent of the participants treated were panic attack free.  Moreover, eighty percent were panic attack free and ninety-three percent reported overall panic symptom reduction at twelve months post-treatment.

Fifty participants were enrolled in the program by Allegheny Health Network therapists who provided the initial training on the Freespira device; patients then took Freespira home for twice daily use and followed up with four weekly visits. The participants were assessed at the start of the program, immediately following the Freespira treatment, and again at six and twelve months post-treatment.

Freespira is an FDA-cleared, in-home digital therapeutic device for panic disorder and panic attacks occurring with other anxiety conditions.  Most people with panic chronically hyperventilate, not just when having a panic attack. Freespira corrects this dysfunctional breathing by using a Sensor and guided breathing Protocol to train patients to normalize their exhaled carbon dioxide level and stabilize their breathing rate – which eliminates or reduces panic attacks and other panic symptoms for at least 12 months post-treatment.

“Highmark Health created the VITAL program to provide promising new, FDA-cleared treatments to patients without undue delays or complexity.  We’re very excited about the results of the Freespira program, both in terms of the immediate and long-term results,” said Sarah Ahmad, Senior Vice President of Innovation, Highmark Health.  “The VITAL program is focused on improving outcomes for participants, while validating and fast-tracking a product that has the potential to improve quality of life for the more than 27 million Americans who experience panic attacks annually.  ”

Panic attacks are primarily associated with anxiety disorders such as generalized anxiety disorder, PTSD, and social anxiety. While panic is often thought of as a mental health condition, individuals also experience debilitating physiologic symptoms like chest pains, feeling faint, nauseous and numbness in the fingers and toes triggered by their breathing irregularities.  Patients often misinterpret these physical sensations as a serious medical event such as heart attack or stroke, leading to over-utilization of medical services, such as ED visits, diagnostic testing, medications, primary and behavioral health provider visits.

“Improving health outcomes for the patient and reducing overall medical costs is a “win-win-win” for the Patient, Provider and Insurer,” said Debra Reisenthel, CEO of Palo Alto Health Sciences, Inc. “These clinical outcomes were consistent with prior clinical trials in different settings, further validating Freespira’s efficacy.”

“We are very excited to see such lasting results from a 1-month, drug-free treatment that can dramatically improve the quality of life for our patients and reduce total medical costs” said Anthony P. Mannarino, Ph.D. Professor and Vice Chair, Department of Psychiatry, Allegheny General Hospital.  “It was also very promising to see high therapist and patient satisfaction and 85% patient adherence , confirming that using Freespira as a first line treatment for panic disorder and panic attacks makes good sense clinically and financially.”

About Highmark Health’s VITAL Innovation Program

VITAL’s mission is to leverage Highmark Health’s position as one of the largest integrated health care delivery and financing systems in the nation to accelerate the pace with which novel technologies and services are made available to our customers. In doing so, members and patients will be afforded access to safe new technologies without undue financial burden while payers will be able to understand the full impact of new technologies on their members without changing insurance medical policy prematurely. Additionally, providers will gain early access to novel technologies and a first-hand understanding of their impact on patients. Technology vendors will have the opportunity to prove the benefits of their new innovations to patients, providers and payers.  More details about Highmark Health’s VITAL Innovation Program can be found at: http://vitalinnovationprogram.org

About Highmark Health
Highmark Health, a Pittsburgh, PA based enterprise that employs more than 40,000 people nationwide and serves nearly 50 million Americans in all 50 states, is the second largest integrated health care delivery and financing network in the nation based on revenue.   Highmark Health is the parent company of Highmark Inc., Allegheny Health Network, and HM Health Solutions.  Highmark Inc. and its subsidiaries and affiliates provide health insurance to nearly 5 million members in Pennsylvania, West Virginia and Delaware as well as dental insurance, vision care and related health products through a national network of diversified businesses that include United Concordia Companies, HM Insurance Group, Davis Vision and Visionworks.   Allegheny Health Network is the parent company of an integrated delivery network that includes eight hospitals, more than 2,800 affiliated physicians, ambulatory surgery centers, an employed physician organization, home and community-based health services, a research institute, a group purchasing organization, and health and wellness pavilions in western Pennsylvania.   HM Health Solutions focuses on meeting the information technology platform and other business needs of the Highmark Health enterprise as well as unaffiliated health insurance plans by providing proven business processes, expert knowledge and integrated cloud-based platforms.  To learn more, please visit www.highmarkhealth.org.

About Palo Alto Health Sciences and Freespira®

Palo Alto Health Sciences, Inc. is a privately held Silicon Valley digital therapeutic company at the forefront of revolutionizing behavioral healthcare with evidence-based, at-home, drug-free solutions. Their first product, Freespira®, is an FDA-cleared treatment for individuals suffering from panic disorder, panic attacks and other symptoms of panic.

Freespira® is commercially available in the U.S. is an FDA-cleared, medication-free, 4-week treatment for panic attacks and other panic symptoms. Treatment is authorized and completed under the supervision of a licensed healthcare provider and is clinically proven to reduce or eliminate panic attacks and other symptoms of panic disorder, a mental health condition in which debilitating anxiety leads to life-altering avoidance behaviors. Individuals with panic chronically hyperventilate, even when not experiencing a panic attack. This abnormal breathing pattern has been shown to exacerbate panic attacks and increase susceptibility to panic symptoms. Freespira uses a custom sensor and twice-daily at-home protocol to train patients to stabilize their respiration rate and exhaled carbon dioxide levels, thereby reducing or eliminating panic attacks. To learn more, please visit: http://www.freespira.com  or contact info@pahealthsciences.com

Media contacts:

Lynn Seay
Director, Corporate Communications
Highmark Health
Lynn.seay@highmarkhealth.org

Sheila McCormick
Media and Marketing
Palo Alto Health Sciences
Email:  Sheila@pahealthsciences.com

Palo Alto Health Sciences Names Amy Perry to Board of Directors

Danville, CA – (August 17, 2017) – Palo Alto Health Sciences, Inc. (PAHS), developer of the Freespira® treatment for panic attacks and panic disorder, today announced that Amy Perry, CEO of the Hospital Division and Senior Vice President of Integrated Care delivery at Atlantic Health System in New Jersey, will join its Board of Directors. Previously the President of Sinai Hospital in Baltimore, Ms. Perry has a long and distinguished career as an executive with health care delivery and hospital systems. “We are very pleased to have Amy join our Board of Directors,” commented Debra Reisenthel, PAHS President and CEO. “She is a passionate advocate for effective and evidence-based mental health treatments and her many years as a senior hospital executive adds significant expertise as we expand our partnerships with insurance companies and health systems to bring Freespira to more patients.” “Freespira offers an important new drug-free option for people suffering from debilitating panic symptoms,” said Ms. Perry. “I am excited to be working with PAHS to improve the lives of patients, while at the same time helping to reduce their cost of care. Freespira is a highly effective, home-based treatment which offers payers, self-insured employers and integrated health systems an important and timely solution as we work together to improve affordability and access for our patients.”

About Panic Attacks Panic attacks affect an estimated 27 million in the U.S., negatively impacting overall quality of life and productivity. Furthermore, panic attacks are often interpreted as symptoms of serious medical conditions such as a heart attack, nausea, lightheadedness which leads to excess emergency room visits, specialty care, tests and medication use. Given the reported five-fold greater annual healthcare resource utilization by these patients, fewer panic attacks are expected to lead to reduced medical utilization and costs.

About Freespira Freespira is an FDA-cleared, non-invasive, drug-free, four-week at-home treatment for panic attacks and panic symptoms. Treatment is authorized and completed under the supervision of a licensed healthcare provider. Freespira is clinically proven to reduce or eliminate panic attacks and other symptoms of panic disorder, a mental health condition in which debilitating anxiety leads to life-altering avoidance behaviors. Many individuals with panic hyperventilate all the time (chronically), even when not experiencing a panic attack. This abnormal breathing pattern has been shown to exacerbate or lead to panic attacks. Freespira works by training the patient to reduce or eliminate the effects of their chronic hyperventilation by stabilizing their respiration rate and exhaled carbon dioxide levels. A recent multi-center clinical trial demonstrated that at 12 months post-treatment, 79% of treated patients were free of panic attacks and 82% reported significant symptom reduction.

About Palo Alto Health Sciences, Inc. Palo Alto Health Sciences, Inc. is a privately held Silicon Valley digital therapeutic company at the forefront of revolutionizing behavioral healthcare with evidence-based, non-invasive, drugfree solutions. Their first product, Freespira, is an FDA-cleared treatment for individuals suffering from panic disorder, panic attacks and other symptoms of panic. In the United States, over 6.7 million adults annually suffer from panic disorder; panic attacks affect a total of 27 million adults in the U.S. every year and are a common component of other anxiety disorders. Freespira is commercially available throughout the U.S. and is currently being evaluated by Anthem and Highmark Health in regional Quality Improvement Programs to assess Freespira’s impact in reducing the elevated medical costs of treating patients with panic disorder. Separate clinical studies are underway to treat adolescents, and to treat veterans with PTSD. To learn more, visit http://www.freespira.com or contact info@pahealthsciences.com

MEDIA CONTACT
Michele Kong
(800) 735-8995
michele@pahealthsciences.com

Freespira® Clinical Data to be Presented at Three Upcoming Conferences

Danville, CA – (May 17, 2017) – Palo Alto Health Sciences, Inc. (PAHS), developer of the Freespira® at-home treatment for panic attacks and panic disorder, today announced that newly-published clinical data will be presented at three professional conferences in May: the 2017 Annual Meeting of the Clinical Transcranial Magnetic Stimulation (TMS) Society, the Special Operations Medical Association, and the 6th Annual Leadership Summit on Integrating Behavioral Health & Primary Care Models. These presentations will describe the latest clinical data on the effectiveness of the Freespira treatment, clinical practice integration, and the emerging use of Freespira to treat panic attacks associated with post-traumatic stress disorder (PTSD), a condition affecting many U.S. veterans.
Authorized by a licensed healthcare provider, Freespira is both easy to use and effective. After a single training session, the patient performs two 17-minute breathing sessions per day at home over a four-week period. A recently published multi-center clinical trial of patients utilizing the Freespira protocol demonstrated that 71% of patients eliminated panic attacks immediately after treatment, and 79% of patients were panic attack free 12 months post-treatment.
Debra Reisenthel, PAHS President and CEO, commented, “Our company is committed to developing innovative, evidence-based treatments for behavioral health conditions. We are excited to be partnering with leading clinicians to perform important new research, which includes studying the use of Freespira in patients with PTSD as well as treating significant anxiety and panic in adolescents.”

About Panic Attacks
Panic attacks affect an estimated 27 million in the U.S., impacting their lives in profoundly negative ways, including overall quality of life and productivity. Furthermore, panic attacks are often misinterpreted as a serious medical event such as a heart attack, which leads to excess emergency room visits, tests, medication use, and doctor visits. Given the five-fold increase in annual use of healthcare resources by these patients, fewer panic attacks are expected to lead to reduced medical utilization and costs.

About Freespira
Freespira is an FDA-cleared, non-invasive, drug-free, four-week at-home treatment for panic attacks and panic symptoms. Treatment is authorized and completed under the supervision of a licensed healthcare provider. Freespira is clinically proven to reduce or eliminate panic attacks and other symptoms of panic disorder, a mental health condition in which debilitating anxiety leads to life-altering avoidance behaviors. Many individuals with panic chronically hyperventilate, even when not experiencing a panic attack. This abnormal breathing pattern has been shown to exacerbate attacks. Freespira works by training the patient to stabilize respiration rate and exhaled carbon dioxide levels, which reduces or eliminates the chronic hyperventilation. A recent multi-center clinical trial demonstrated that at 12 months post-treatment, 79% of treated patients were free of panic attacks and 82% had significant symptom reduction.

About Palo Alto Health Sciences, Inc.
Palo Alto Health Sciences, Inc. is a privately held Silicon Valley digital therapeutic company at the forefront of revolutionizing behavioral healthcare with evidence-based, non-invasive, drug-free solutions. Their first product, Freespira, is an FDA-cleared treatment for individuals suffering from panic disorder, panic attacks and other symptoms of panic. In the United States, over 6.7 million adults annually suffer from panic disorder; panic attacks affect a total of 27 million adults in the U.S. every year and are a common component of other anxiety disorders.
Freespira is commercially available throughout the U.S. and is currently being evaluated by Anthem and Highmark Health in regional Quality Improvement Programs to assess Freespira’s impact in reducing the elevated medical costs of treating patients with panic disorder.

Separate clinical studies are underway to treat adolescents, and to treat veterans with PTSD.
To learn more, visit http://www.freespira.com or contact info@pahealthsciences.com.

MEDIA CONTACT
Michele Kong
(800) 735-8995
michele@pahealthsciences.com

Palo Alto Health Sciences Partners with Silicon Valley TMS Integrated Clinical Neurosciences to Offer Freespira® Treatment for Panic Attacks and Panic Disorder

Danville, CA – (May 2, 2017) – Palo Alto Health Sciences, Inc. (PAHS), developer of the Freespira® treatment for panic attacks and other symptoms of panic disorder, today announced that it has partnered with Silicon Valley TMS, the leading San Francisco Bay Area provider of neuro-psychiatric services, to offer the Freespira Program.
The Freespira Program is a comprehensive and medication-free treatment for patients with panic. The patient, once authorized, is trained by a technician and then takes Freespira home to perform two, 17-minute breathing sessions a day for four weeks. During treatment, the patient is remotely monitored and coached by the PAHS practice coordination team. When the four-week treatment is complete, the patient returns to the Clinic for a follow-up visit.

A recently published multi-center Freespira clinical trial demonstrated that 71% of patients eliminated panic attacks immediately after treatment, and 79% of patients were panic attack free 12 months post-treatment.

Silicon Valley TMS Founder and Chief Medical Officer Dr. Saad A. Shakir comments, “Freespira is an excellent fit with our Clinics because we can now offer patients the most advanced, medication-free and evidence-based treatments for depression, anxiety and panic. It is not uncommon for patients suffering from depression to also suffer from other mental health conditions, including panic attacks and panic disorder.”

Dr. Shakir added, “We’re happy to provide the most effective care to our patients and community. Freespira provides an innovative approach to treat panic attacks and panic disorder without using medications. This complements the other modalities of treatment that we provide within our multidisciplinary and comprehensive group practice.”
Debra Reisenthel, PAHS CEO, agreed, “Freespira offers hope to the many patients with panic attacks and panic disorder who prefer a non-drug approach because of the side effects of medications, or who have not tried or have not responded to talk therapies. We are excited to partner with Dr. Shakir and Silicon Valley TMS to offer the Freespira Program to help even more patients in the San Francisco Bay Area.“

About Freespira
Freespira is an FDA-cleared, non-invasive, medication-free, four-week at-home treatment for panic attacks and other panic symptoms. Treatment is authorized and completed under the supervision of a licensed healthcare provider. Freespira is clinically proven to reduce or eliminate panic attacks and other symptoms of panic disorder, a mental health condition in which debilitating anxiety leads to life-altering avoidance behaviors. Individuals with panic chronically hyperventilate, even when not experiencing a panic attack. This abnormal breathing pattern has been shown to exacerbate attacks. Freespira works by training the patient to stabilize respiration rate and exhaled carbon dioxide levels, which reduces or eliminates panic attacks.

About Silicon Valley TMS
Silicon Valley TMS provides patients in the Bay Area with the latest in evidence-based mental health treatments including Transcranial Magnetic Stimulation (r-TMS) such as Neurostar® TMS Therapy system and Brainsway Deep TMS Therapy. TMS is one of the most technologically advanced depression treatments available. This non-invasive, FDA cleared (2008), outpatient therapy has helped thousands of patients with depression and other neuro-psychiatric conditions, who have not received adequate results from medications and psychotherapies.
Silicon Valley TMS was founded by Saad A. Shakir, MD, and associates (Integrated Clinical Neurosciences) as part of their private practice group in December 2010.
http://www.siliconvalleytms.com/

About Palo Alto Health Sciences, Inc.
Palo Alto Health Sciences, Inc. is a privately held digital therapeutic company at the forefront of revolutionizing behavioral healthcare with evidence-based, non-invasive, drug-free solutions.
Their first product, Freespira, is an FDA-cleared treatment for individuals suffering from panic disorder, panic attacks and other symptoms of panic. In the United States, over 6.7 million adults annually suffer from panic disorder; panic attacks affect a total of 27 million adults in the U.S. every year and are a common component of other anxiety disorders.
Freespira is commercially available throughout the U.S. and is currently being evaluated by Anthem and Highmark Health in regional Quality Improvement Programs to assess Freespira’s impact in reducing the elevated medical costs of treating patients with panic disorder. To learn more, visit http://www.freespira.com or contact info@pahealthsciences.com.

MEDIA CONTACT
Michele Kong
(800) 735- 8995
michele@pahealthsciences.com

Next Generation Freespira® System for Panic Attacks to be Unveiled at Anxiety and Depression Association of America Conference

Danville, CA – (April 4, 2017) – Palo Alto Health Sciences, Inc. (PAHS), developer of the Freespira® at-home treatment for panic attacks and panic disorder, today announced that the latest generation Freespira System will be debuted at the Anxiety and Depression Association of America’s Annual Conference April 6-9 in San Francisco. Sleeker and more ergonomic, the new Freespira handheld sensor provides quicker start-up and improved ease of use, enhancing the patient’s experience and adherence. As in prior designs, Freespira seamlessly uploads
treatment data to a secure server for clinical review and monitoring, which facilitates patient and provider engagement.
Offered under the supervision of a licensed healthcare provider and completed in the convenience and privacy of the patient’s home, the Freespira treatment is both simple and effective. With only two 17-minute breathing sessions a day over a four-week period, 71% of patients in a recently published multi-center clinical trial eliminated panic attacks immediately after treatment. At 12 months post-treatment, 79% of patients were panic attack free.
Palo Alto Health Sciences’ Chief Clinical Officer, Robert Cuyler, PhD, commented, “Patients report high satisfaction with the Freespira System’s ease of use and clinical benefit. Moreover, many Freespira patients report feeling better in only a couple of weeks, which further motivates them to continue the treatment.”
Debra Reisenthel, PAHS President and CEO added, “The latest generation of Freespira demonstrates our ongoing commitment to continued research and product development, as well as our goal to exceed patient and clinician expectations of the Freespira treatment.”

The Cost of Panic
Panic attacks affect an estimated 27 million in the U.S., impacting their lives in profoundly negative ways, including overall quality of life and productivity. Furthermore, panic attacks are often misinterpreted as a serious medical event such as a heart attack, which leads to excess emergency room visits, tests, medication use, and doctor visits. Given the five-fold increase in annual use of healthcare resources by these patients, fewer panic attacks are expected to lead to reduced medical utilization and costs.

About Freespira
Freespira is an FDA-cleared, non-invasive, drug-free, four-week at-home treatment for panic attacks and panic symptoms. Treatment is authorized and completed under the supervision of a licensed healthcare provider. Freespira is clinically proven to reduce or eliminate panic attacks and symptoms of panic disorder, a mental health condition in which debilitating anxiety leads to life-altering avoidance behaviors. Many individuals with panic chronically hyperventilate, even when not experiencing a panic attack. This abnormal breathing pattern has been shown to exacerbate attacks. Freespira works by training the patient to stabilize respiration rate and exhaled carbon dioxide levels, which reduces or eliminates the chronic hyperventilation. A recent multi-center clinical trial demonstrated that at 12 months post-treatment, 79% of treated patients were free of panic attacks and 82% had significant symptom reduction.

About Palo Alto Health Sciences, Inc.
Palo Alto Health Sciences, Inc. is a privately held Silicon Valley digital therapeutic company at the forefront of revolutionizing behavioral healthcare with evidence-based, non-invasive, drug-free solutions. Their first product, Freespira, is an FDA-cleared treatment for individuals suffering from panic disorder, panic attacks and other symptoms of panic. In the United States, over 6.7 million adults annually suffer from panic disorder; panic attacks affect a total of 27 million adults in the U.S. every year and are a common component of other anxiety disorders.
Freespira is commercially available throughout the U.S. and is currently being evaluated by Anthem and Highmark Health in regional Quality Improvement Programs to assess Freespira’s impact in reducing the elevated medical costs of treating patients with panic disorder. To learn more, visit http://www.freespira.com or contact info@pahealthsciences.com.

MEDIA CONTACT
Michele Kong
(800) 735-8995
michele@pahealthsciences.com

New Freespira® Study Shows Nearly 80% of Patients are Panic Attack Free at One Year Post-Treatment

The drug-free, four-week at-home treatment produces lasting results

Danville, CA – (February 22, 2017) – Palo Alto Health Sciences, Inc. (PAHS), developer of the Freespira® at-home treatment for panic attacks and other symptoms of panic disorder, today announced the results of a new multi-center clinical trial which demonstrated compelling effectiveness across a broad spectrum of patient demographics and symptom severity. Results were published in the peer-reviewed journal Applied Psychophysiology and Biofeedback.

Authorized by a licensed healthcare provider and completed in the convenience and privacy of the patient’s own home, the Freespira treatment is both simple and effective. With only two 17-minute sessions a day over a four-week period, most patients reduced or eliminated panic attacks and maintained that improvement for at least 12 months.

Principal Investigator David Tolin Ph.D., Director of Anxiety Disorders Center, The Institute of Living, and Adjunct Professor of Psychiatry, Yale University School of Medicine said, “Freespira is a validated new treatment option for patients with panic disorder. It is simple, effective, and drug-free, and the results are durable for at least 12 months after treatment is completed. This latest study confirms the results seen in a prior study at a single academic center and, importantly, demonstrates that the Freespira treatment is equally effective and safe when
provided in the community setting.”

PAHS CEO Debra Reisenthel commented, “Freespira offers patients suffering from the debilitating symptoms of panic attacks a safe, effective, at-home and drug-free option. At one
year, the clear majority of patients in the study are living panic attack free.”

The published paper can be viewed for free here
http://link.springer.com/article/10.1007/s10484-017-9354-4

The Cost of Panic.
Panic attacks affect millions in the U.S., impacting their lives in profoundly negative ways, and especially impairing their ability to work. Panic attacks are often misinterpreted as a serious medical event such as a heart attack, which leads to excess emergency room visits, tests, medication use, and doctor visits. Given the five-fold increase in annual use of healthcare resources by these patients, fewer panic attacks are expected to lead to reduced medical utilization and costs.

About Freespira.
Freespira is an FDA-cleared, drug-free, four-week at-home treatment for panic attacks and other panic symptoms. Treatment is completed under the supervision of a licensed healthcare provider. Freespira is clinically proven to reduce or eliminate panic attacks and other symptoms of panic disorder, a mental health condition in which debilitating anxiety leads to life-altering avoidance behaviors. Individuals with panic often chronically hyperventilate, even when not experiencing a panic attack. This abnormal breathing pattern has been shown to exacerbate
attacks. Freespira works by training the patient to stabilize their respiration rate and exhaled carbon dioxide levels, which reduces or eliminates panic attacks. This clinical trial demonstrated that at 12-months post-treatment 79% of treated patients were free of panic attacks and 82% had symptom reduction.

About Palo Alto Health Sciences, Inc.
Palo Alto Health Sciences, Inc. is a privately held Silicon Valley digital therapeutic company at the forefront of revolutionizing behavioral healthcare with evidence-based, non-invasive, drugfree solutions. Their first product, Freespira, is an FDA-cleared treatment for individuals suffering from panic attacks and panic symptoms. In the United States, over 6.7 million adults annually suffer from panic disorder; panic attacks affect a total of 27 million adults in the U.S. every year and are a common component of other anxiety disorders.

Freespira is commercially available throughout the U.S. and is currently being evaluated by Anthem and Highmark Health in regional Quality Improvement Programs to assess Freespira’s impact in reducing the elevated medical costs of treating patients with panic disorder. To learn more, visit http://www.freespira.com or contact info@pahealthsciences.com.

MEDIA CONTACT
Michele Kong
(925) 594-8404
michele@pahealthsciences.com