How to Convince Investors, Payers, and Patients Your Device is Worth the Cost: Interview with Bone Health Technologies CEO Laura Yecies

About 54 million Americans have osteoporosis and low bone mass, which can lead to serious and painful bone fractures. Studies estimate that about one in two women and up to one in four men ages 50 and up who have the condition will break a bone, according to the Bone Health Policy Institute.

Though osteoporosis is a common condition, there are gaps in treatment — some can put patients at risk for further fractures while others have relatively low patient adherence rates.

Laura Yecies understood that need, which is why she became CEO of medtech startup Bone Health Technologies in 2020.

Laura is a Silicon Valley veteran with 30 years of experience leading major companies, including Netscape, Yahoo, SugarSync, and CheckPoint, as well as startups such as SyncThink and Catch.

She’s always had a deep-rooted interest in people’s health and wellness and was looking for her next big project — something she could connect with on a personal level.

That’s when she came across Bone Health Technologies and its OsteoBoost belt, which is intended to prevent osteoporosis. Wrapped around the user’s waist, the belt produces gentle vibrations that mechanically stimulate the bones to improve bone density.

The National Institutes of Health’s National Institute on Aging awarded Bone Health Technologies a $2.7 million grant to help fund the company’s late-stage research and development.

Bone Health Technologies also is currently enrolling participants in a one-year study assessing whether OsteoBoost can successfully treat osteopenia in postmenopausal women. They are conducting the trial in partnership with the San Francisco Veterans Affairs Health Care System; the University of California, San Francisco; and the Northern California Institute for Research and Education.

In this episode of Medsider, Laura talks about the importance of finding investors who are passionate about your mission, why Bone Health Technologies decided to pursue FDA clearance for its technology, and how the company’s commercial plans through a cash-pay approach.

Guest

Laura Yecies

CEO of Bone Health Technologies

Laura Yecies is a Silicon Valley veteran with more than three decades of experience at major tech companies and startups. She’s always had an interest in improving people’s health and wellness and was drawn to medtech startup Bone Health Technologies, which is developing a vibration belt intended to prevent osteoporosis.

Key Lessons from Laura’s Experiences

  • Identify the right investors. Find people who connect with your company’s message and mission, and are passionate about your product.
  • Consider getting the FDA stamp of approval, even with a consumer-centric device. Taking your products through the regulatory process is expensive and time-consuming, but can boost patient and provider confidence in your technology.
  • Think about how patients will pay for your product and price it accordingly. Bone Health Technologies is pursuing and making a commitment to an affordable self-pay path (for now).

Identify the Right Investors for Your Product

Find groups that connect with your mission and message, Laura says.

Bone Health Technologies’ investors fall into a couple of different categories: clinical experts who understand the unmet medical need in osteoporosis, and groups that are focused on women’s health and want to invest in women-led companies.

Laura found many of the company’s investors also have personal experience with osteoporosis or know someone who does, and as a result, they are all very passionate about what Bone Health Technologies is doing in the space.

“I think that’s important. You see this generally with angel investors. They’re making a considerable financial decision, but oftentimes, they’re investing in fields that they care about. And I think that passion and care are important for all of the roles,” she says.

Once you identify investors, you need to perfect your pitch. Be clear about the need for your product, Laura advises.

If the need is small, be prepared to explain where you see demand for your product and how investors will benefit financially. You shouldn’t have to work too hard to prove there’s demand, Laura says.

“If you're working too hard on that, something’s wrong and the investors will see it,” she says.

Pick Your Regulatory Path Wisely

Going through the FDA premarket clearance path is a lengthy endeavor and can be expensive, but Bone Health Technologies thinks the time spent will be worth the effort.

Doctors and patients generally trust the FDA stamp of approval — all the more reason to pursue a clinical development strategy through the agency, Laura says.

Bone Health Technologies initially tested its product as a device marketed OTC (over the counter). While people were interested in the product, they were hesitant to spend money upfront without the rigorous clinical data to back it up.

“The science is good, but from a market perspective, we recognize that there’s potential for skepticism. That’s all the more reason to hold ourselves to the most rigorous data standards,” Laura says.

The company decided to forego the OTC route (for now) and instead pursue a Class II FDA authorization pathway for OsteoBoost, which Laura says will also allow insurance to cover the device.

In 2020 FDA granted breakthrough device designation to the OsteoBoost belt, meaning Bone Health Technologies will have more frequent interactions with FDA reviewers throughout the product development stages. The company’s more rigorous clinical strategy should also yield fruit in the future should it want to pursue the OTC market.

There are a lot of products that started out as prescription and transitioned to OTC, and the OTC version benefits from the prescription version’s “seal of approval,” Laura says.

Consider How Patients Will Pay for Your Product

Bone Health Technologies focuses on making its product affordable so that patients can pay out of pocket.

“We haven't set pricing yet but we are aiming for something that is reasonable. It seems like a no-brainer decision,” Laura says.

Laura expects the device will prove useful in curbing more serious, expensive bone injuries, which could eventually spark interest among payers, including Medicare.

Most bone fractures due to osteoporosis occur in senior citizens, who are often Medicare patients. Fractures are on the rise, are costly to treat, and get expensive for payers. But those costs can be headed off with a relatively inexpensive device, Laura says.

OsteoBoost has not been assigned a current procedural terminology (CPT) code — a five-digit number that providers use to identify medical services and procedures for insurance claims. The device also is not covered by insurance, but the ultimate goal is to have a CPT code and coverage, Laura says.

In the absence of insurance coverage, Bone Health Technologies will let patients pay out of pocket for the device. As there are 50 to 60 million osteoporosis patients, Laura expects there will be enough demand for OsteoBoost that the company will be able to make a lot of headway with a cash-pay approach out of the gate.

Laura also acknowledges that many people who would benefit from OsteoBoost are on a fixed income and might not be able to pay out of pocket, which is why the company plans on working overtime to obtain insurance coverage.

“It's important from a health equity point of view, and of course, as a business opportunity for us. But we can start and we can make progress at the beginning with self-pay,” she says.

At the end of the day it’s about the patients — understanding their health journey, their needs, and what they want out of a product — and then communicating that with investors so you have the resources to bring that product to fruition. The more you know about the patient, the better and more successful your product will be, Laura says.

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