MedTech Pioneers – Cala Health’s First-to-Market Bioelectronic Medicine for Hand Tremors

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What is the genesis of Cala Health?

(RR) Cala Health is a spinout of Stanford Biodesign. Founder and Chief Scientific Officer Kate Rosenbluth pitched her wearable neuromodulation concept to Johnson & Johnson (J&J). At J&J, we had invested in dozens of neuromodulation companies over many years, but it was all implantable! So the ability to deliver bioelectronic medicine through a wearable form factor was super intriguing. So, as Kate was packing up her computer, I followed her out the door and insisted that we start a company. Six weeks later, Cala Health was born!

What drew you to Cala Health?

(RR) I have been heavily invested from the beginning. J&J led Cala’s series A with Lux Capital, and I joined Cala’s board. In the beginning, we established a “Cala Clinic” so we could run IRB studies, collect a lot of great data on user experience, and perform rapid clinical studies. We then raised a larger series B with Lightstone Capital; we had four strategic investors, too. This allowed us to drive momentum to FDA clearance. As we were then finalizing Cala’s series C in 2019, the board decided to look for a CEO with commercial leadership and experience spanning medical devices, pharma, and consumer health.

It was that unique set of requirements that made the search almost like looking for a needle in a haystack, so the search was taking some time. It was actually my husband who suggested to me that I “apply”. I remember his insistence that my eight years at JJDC overseeing a portfolio of $2+B of investments across medtech/pharma/consumer made me uniquely suited for the role. After a couple of days with no sleep, I threw my name in the hat.  Funny, they took me off the “search committee” and I interviewed alongside all the other candidates! By July 2019, I was offered the position and accepted immediately.

Tell us more about Essential Tremor (ET) and Active Tremors

(RR) Essential Tremor (ET) is the most prevalent movement disorder and one of the most common neurological disorders, affecting an estimated seven million people in the United States. It is a chronic condition that causes involuntary and rhythmic shaking and typically worsens over time. ET can affect almost any part of the body, but the trembling most often occurs in the hands, making everyday activities, such as eating, writing, or getting dressed, extremely difficult. ET is often confused with Parkinson’s disease, although it is eight times more common.

Action tremor occurs with the voluntary movement of a muscle. Most types of tremor are considered action tremor.

Tell us about Cala’s science

(RR) Kate had done her undergrad at Stanford, received her PhD in Bioengineering at UC Berkeley and UCSF, and postdoctoral fellowship in Translational Neuroscience at UCSF. She is the voice of science at Cala. She had done extensive work in deep brain stimulation, primarily in Parkinson’s disease. At Stanford, she began to spend time with ET patients and saw how often they struggled with self-care. Her hypothesis was that the ability to treat ET by stimulating nerves at the wrist in a specific pattern would address the exact location in the brain (the central tremor network) that DBS targets for ET. At Stanford she treated 13 patients and I saw firsthand the power of the technology as the tremors subsided in real time. Since founding Cala, we have seen other companies applying various drug or ablative technologies that target this exact location in the brain. This has been a strong validation to us of our science.

How does the technology work?

(RR) Cala Health is pioneering a new class of wearable neuromodulation therapies.  Key to our technology is the link between sensors that are reading physiologic signals from the body to calibrate or personalize our therapeutic electrical signals.   Our wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation. Cala Health’s lead product, Cala Trio™, is the first and only non-invasive prescription therapy for essential tremor (ET).

How does Cala differ from competitors in the space?

(RR) In the arena of devices applying electricity to the body, there are a lot of competitors, but none are approaching it in the same “science first” manner that Cala has been pursuing. Since day one, we have invested in very rich basic science work to understand the fundamental mechanism of action of our therapies. In ET, patients have few options. On the pharmaceutical side, physicians can prescribe generic beta blockers and anti-epileptic seizure medications that require high doses in order to achieve therapeutic benefit, so they are also fairly expensive. Ablation of certain brain tissue is another surgical option on top of DBS, but both are invasive and have significant side effects. What has been really interesting is that the whole tremor conversation is being elevated and the key beneficiaries of that are the patients who really need options!

How does one use the Trio™ device?

(RR) The Cala Trio is a fairly simple, wrist-worn device that is calibrated to treat a patient’s unique tremor symptoms. When activated, Cala Trio gently stimulates the nerves in the wrist to disrupt the tremulous activity and reduce the tremor amplitude in the patient’s hands. The patient simply presses the start button to begin a 40-minute neurostim session, and in 10–15 minutes, they will begin to see the tremors reduce. In many cases, patients continue to see reduced tremor for an additional 60–90 minutes after the session. Cala Trio can be prescribed through an in-person consultation or telemedicine appointment. Therapy is delivered to the patient’s home, and Cala Health educates patients directly or digitally.

What are recent milestones for Cala?

(RR) In October 2020 we achieved Breakthrough Device Designation status from the FDA for a label expansion into Parkinson’s disease action tremors. We are currently performing clinical studies evaluating action tremor reduction in Parkinson’s disease patients.

How has COVID-19 impacted the Cala team and business?

(RR) COVID-19 was a shock to everyone’s system and taught us to operate in new ways. Cala Health’s business grew in 2020. We were able to hit our objectives and secure the learnings we wanted. When we first began sheltering in place during the COVID-19 shutdown, we had to suspend enrollment in our clinical studies. By May 2020 we had resumed our studies by adopting our commercial model (direct shipment of devices to a patient’s home) in our clinical plan. We have become really efficient and effective at running clinical studies virtually via remote care and telehealth.

I have worked through two global crises, first as a VP/Director during 9/11 and again as a Partner level in the financial crisis of 2006-7. I learned that if you lean heavily on your partners and you all lean in together, you will emerge stronger. We pulled the Cala team together and our bond became stronger. For everyone who leaned in, we got to know them in different ways, and we are all now stronger as a team.

Tell us about a Cala patient

(RR) Oh, Lisa, too many to count! When a clinical study ends, the patient sends the Trio™ device back to us. In our ongoing Parkinson’s Disease study, we recently had one patient send the device back with a lovely thank you note. She wrote that for the first time since she could remember, she was able to highlight passages in her bible and make Christmas cookies with her granddaughter. These stories are shared pretty widely around the company, and we love the ability to positively impact people’s lives in a meaningful way.

What is next on the horizon for Cala?

(RR) Upcoming milestones include continued expansion of clinical studies in our key movement disorder targets (ET and Parkinson’s) and expanding our portfolio in neurology, psychiatry, and cardiology.

What is your vision for Cala Health?

(RR) Cala combines breakthrough insights in neuroscience with proprietary hardware. We wrap that in a rich data science platform to drive better insights and therapy for our patients. But we start with science and mechanism of action work, and then we move onto rich clinical data sets to gain acceptance by key thought leaders and physicians. Then we deliver to our patients in a “one touch” business model. Ultimately, we want to expand the portfolio to serve more patients.

What accomplishments are you most proud of?

(RR) While at J&J, I managed one other investor. We started a handful of companies together, managed a lot of portfolio investments, and had a lot of fun, but it was just the two of us. I missed managing people and helping them to advance their careers. At Cala, we have an amazing team and we all complement each other. And we all challenge one another to bring our best — we have some very lofty goals!

“I am most proud that Kate Rosenbluth, our founder and Chief Science Officer, stayed on board. She is much of the DNA of Cala Health. As we continue to do our work “the Cala way”, I am so excited to do it with Kate!”