Cala Health Company Profile

Background

Cala Health is a bioelectronic medicine company dedicated to transforming the standard of care for chronic diseases through non-invasive neuromodulation therapies. Founded in 2014 and headquartered in San Mateo, California, the company focuses on developing wearable devices that deliver individualized peripheral nerve stimulation. Their mission is to free individuals from the burden of chronic disease by merging innovations in neuroscience, electronics, and medical devices. Cala Health's flagship product, the Cala kIQ System, is designed to treat hand tremors associated with essential tremor (ET) and Parkinson's disease.

Key Strategic Focus

Cala Health's strategic objectives include:

Product Innovation: Advancing the development of non-invasive neuromodulation therapies, exemplified by the Cala kIQ System, which utilizes Transcutaneous Afferent Patterned Stimulation (TAPS) therapy to reduce hand tremors.

Market Expansion: Extending the application of their bioelectronic medicine platform beyond movement disorders to address conditions in neurology, cardiology, psychiatry, and autoimmune diseases.

Regulatory Advancement: Securing FDA clearances and breakthrough device designations to facilitate market entry and adoption of their therapies.

Strategic Partnerships: Collaborating with leading healthcare institutions and research organizations to enhance product development and clinical validation.

Financials and Funding

Cala Health has successfully secured substantial funding to support its growth and innovation initiatives:

Total Funding: Approximately $148.3 million raised through multiple funding rounds.

Series D Funding: In November 2021, the company raised $77 million in a Series D round led by Ascension Ventures, with participation from Dolby Family Ventures, PEAK6 Strategic Capital, and Innovatus Capital Partners.

Series C Funding: In May 2019, Cala Health secured $50 million in a Series C round.

Utilization of Capital: The funds have been allocated to expand patient access, accelerate product innovation, and establish partnerships with payers to enhance reimbursement pathways.

Pipeline Development

Cala Health's product pipeline is centered around the development and commercialization of non-invasive neuromodulation therapies:

Cala kIQ System: Launched in April 2023, this next-generation device delivers TAPS therapy for the treatment of hand tremors in patients with essential tremor and Parkinson's disease.

Clinical Validation: The PROSPECT study, completed in December 2019, demonstrated that repeated home use of TAPS therapy over three months resulted in safe and effective hand tremor reduction and improvements in quality of life for adults with essential tremor.

Future Indications: The company is exploring applications of its bioelectronic medicine platform in other areas, including cardiology, psychiatry, and autoimmune diseases.

Technological Platform and Innovation

Cala Health's innovation is underpinned by its proprietary technological platform:

Transcutaneous Afferent Patterned Stimulation (TAPS): A non-invasive therapy that delivers patterned electrical stimulation to peripheral nerves, tailored to each patient's unique tremor signature.

Wearable Device Integration: The Cala kIQ System is a wrist-worn device that provides individualized therapy, enhancing patient compliance and ease of use.

Data Analytics: The MyCala.com patient portal offers online data insights that can be shared with healthcare providers, facilitating personalized treatment plans and monitoring.

Leadership Team

Cala Health's leadership comprises experienced professionals dedicated to advancing bioelectronic medicine:

Deanna Harshbarger: Appointed as Chief Executive Officer in June 2024, bringing extensive experience in medical device commercialization and strategic growth.

Kate Rosenbluth, PhD: Founder and President & Chief Innovation Officer, instrumental in developing the company's core technologies and guiding its innovation strategy.

Steve Higa: Vice President of Manufacturing & Quality, overseeing product manufacturing processes and quality assurance.

Greg Schulte: Vice President of Technology, leading the development and integration of technological solutions within the company's product offerings.

Leadership Changes

June 2024: Deanna Harshbarger appointed as Chief Executive Officer, succeeding Renee Ryan.

June 2024: Founder Kate Rosenbluth assumes the role of President & Chief Innovation Officer, focusing on driving the company's innovation initiatives.

Competitor Profile

Market Insights and Dynamics

Market Size and Growth: The bioelectronic medicine market was valued at approximately $3.5 billion in 2022, with projections indicating continued growth due to increasing prevalence of chronic diseases and demand for non-invasive therapies.

Industry Trends: There is a significant shift towards personalized medicine and non-pharmacological treatments, driving innovation in neuromodulation therapies.

Competitor Analysis

Medtronic: A global leader in medical technology, offering a range of neurostimulation devices for chronic pain and movement disorders.

Abbott Laboratories: Provides implantable neuromodulation devices for chronic pain and neurological conditions.

Boston Scientific: Develops neurostimulation systems for managing chronic pain and other neurological disorders.

SetPoint Medical: Focuses on bioelectronic medicine for inflammatory diseases, developing implantable devices for neuromodulation therapy.

Steadiwear: Specializes in wearable devices designed to reduce hand tremors, offering non-invasive solutions for patients with movement disorders.

GyroGear: Develops gyroscopic wearable devices aimed at stabilizing hand tremors, providing mechanical solutions for tremor management.

Strategic Collaborations and Partnerships

Cala Health has established significant collaborations to enhance its market position and innovation capacity:

University of California, San Francisco (UCSF): Partnered to develop next-generation, smart neuromodulation therapies.

SK Biopharmaceuticals: Collaborated to explore new indications in neurology, expanding the application of Cala Health's bioelectronic medicine platform.

Operational Insights

Cala Health's strategic considerations include:

Market Positioning: Differentiating through non-invasive, patient-specific neuromodulation therapies that offer alternatives to pharmacological and surgical treatments.

Competitive Advantages: Leveraging proprietary TAPS technology, strong clinical validation, and a focus on patient-centric design to stand out in the bioelectronic medicine market.

Strategic Opportunities and Future Directions

Cala Health's strategic roadmap encompasses:

Product Diversification: Expanding the application of TAPS therapy to address a broader range of chronic conditions beyond movement disorders.

Global Expansion: Entering international markets to increase accessibility to their therapies and address unmet medical needs worldwide.

Technological Innovation: Continuing to invest in research and development to enhance the efficacy and user experience of their neuromodulation devices.