Orchestra BioMed is paving a unique path in the medical device industry with its innovative and collaborative approach. Under the leadership of David Hochman, a veteran entrepreneur with a diverse background spanning decades, the company has struck a chord by creating high-impact medical devices and the collaborative infrastructure that makes it possible for more to come. David puts it this way, “Our model tries to break those barriers now. We're only going to win when you win."
David is an entrepreneur and venture capitalist with over two decades of experience who has dedicated his career to developing purpose-oriented medical devices. His enthusiasm for medtech innovation is nothing short of contagious.
After various roles in telecom and media — industries worlds apart from the life sciences — he delved into venture capital, focusing initially on biotech investments before shifting to medtech. “I was really driven by what we refer to as a double benefit. If we're going to make money and generate returns for investors, we're only going to do that because we've impacted patients and provided tools or solutions to care providers,” he recalls.
When David realized that medtech offered a unique opportunity to turn ideas into products and, subsequently, into profitable ventures, he helped co-found a company in interventional cardiology in the early 2000s, which allowed him to work closely with key opinion leaders in the field. “What drew me to medical device innovation, at least in the early days, was this perceived shorter cycle of both turning an idea into a product, as well as turning that work into a return on investment,” he explains.
However, the landscape of device innovation shifted significantly around 2008. Larger companies were no longer readily acquiring early-stage, pre-revenue startups. Plus, timelines were getting longer, largely driven by growingly complex clinical trials and more rigorous regulatory guidelines. All of these challenges required more capital and fueled David and his team’s determination to reevaluate their approach. Orchestra BioMed was born in 2018 in response to this, drawing inspiration from the biotech industry's partnership-driven model.
The vision of the company was to seek alignment with established global medtech strategics by setting up a collaborative structure that allowed them to share both risks and rewards. By supplementing the R&D capabilities of larger companies, Orchestra BioMed was able to bring innovative products to market more efficiently.
Orchestra is not just an investor or accelerator. It is an operating company with unique capabilities to drive research, development, and clinical trials. David takes pride in having assembled a team of seasoned executives, each averaging over 25 years of experience, who share a passion for their work.
As David puts it, they aspire to inspire the industry by demonstrating that alternative approaches can yield success. As Orchestra continues to grow and forge partnerships with industry giants like Medtronic and Terumo, David and his team are challenging traditional norms in the medtech industry. He says, “If we do our job well, we won't be the only people doing it this way. We're looking to be flattered by other people realizing this is the smart way to do things, rather than trying to do everything by themselves.”
Their two flagship products, BackBeat CNT and Virtue SAB were born from this collaborative spirit.
BackBeat CNT, also known as Atrioventricular Interval Modulation Therapy (A-V-I-M therapy), tackles a major global health issue: high blood pressure, affecting over a billion people worldwide. It's designed as an add-on for standard pacemakers, requiring no hardware changes. Instead, it uses the pacemaker's capabilities to control blood pressure and adjust the autonomic nervous system's responses. This is especially helpful for patients with both pacemakers and high blood pressure, which is quite common. BackBeat CNT has the potential to benefit millions of pacemaker patients, making it a significant advancement in cardiovascular care.
The second product, Virtue SAB, is designed to enhance angioplasty procedures. Unlike traditional drug-coated balloons, Virtue SAB uses a microporous balloon to deliver sirolimus, a proven anti-restenotic drug, directly to the target area. The design allows for precise drug delivery while eliminating the risk of drug-coating particulates. By ensuring the drug reaches the target area directly, Virtue SAB provides extended focal release of sirolimus over approximately 30 days.
Orchestra BioMed's flagship product, BackBeat CNT, has received full IDE (Investigational Device Exemption) approval from the FDA. While Virtue SAB has received conditional IDE approval, David’s team is actively looking to apply their model to more groundbreaking technologies.
Key Learnings From David’s Experience
- Embrace creativity in structuring partnerships and business models. The nature of collaboration depends on you and your partner organization’s vision, capabilities, and long-term goals. When done right, sharing risks and rewards can be highly productive.
- Having robust operational capabilities enables you to generate more clinically meaningful data. The more impactful the data, the more value you can build.
- Prioritize a long-term outlook over short-term gains. Do not cut corners in favor of reaching certain milestones, especially in clinical trials that ladder up to your regulatory strategy.
David Hockman, founder and CEO of Orchestra BioMed, has over two decades of experience in healthcare entrepreneurship, venture capital, and investment banking. He has a history of leading successful medical startups, including Orchestra Medical Ventures and Accelerated Technologies. As Chairman of Motus GI and former board member of Corbus Pharmaceuticals and PROLOR Biotech, David has been instrumental in advancing medical technologies, contributing to significant mergers & acquisitions, and many fundraising successes.
Partnerships With Shared Risks and Rewards
David's journey began with a noble goal: to create medical devices that generate profits while making a meaningful impact on society.
As the landscape evolved, David skillfully borrowed and adapted the risk- and reward-sharing concept from the biotech industry, reshaping it for medtech. It’s the main principle Orchestra BioMed operates on.
What sets Orchestra apart from other medtech companies is its collaborative business model. They are not investors, nor an accelerator. David says, “We're going to be an operating business that has the ability to execute research and development and clinical programs.” They are breaking down barriers that often exist in discussions with large strategics. Instead of the traditional stilted conversations centered around potential acquisitions, Orchestra looks for ways to collaborate long-term.
Orchestra’s programs are wholly-owned subsidiaries of the company. They meticulously structure each one, complete with legal, financial, and operational frameworks. A joint steering body ensures the alignment of interests, facilitating efficient decision-making. Each program is unique and requires the Orchestra team to tailor their approach for optimal flexibility.
Their partnership with Medtronic, for example, has proven to be quite successful. The AVIM technology has been adeptly integrated into Medtronic's pacemaker devices after thorough testing. “We worked with them very carefully to design the trial that we got the approval for, and the partnership has the potential to expand to other indications," David explains.
Forming win-win partnerships should be the goal, but it's essential to weigh all factors before joining forces with another company. A well-thought-out collaboration can be very productive, but others can be risky.
David summarizes: "It wasn't easy to put together, but I will say it's going really well — we've accomplished a lot in a year, and we're excited about what we'll accomplish over the next couple of years and so on."
Meaningful Data Should Steer the Wheel
The robust infrastructure Orchestra has built with its networks makes it capable of conducting research, development, and clinical trials very efficiently.
David emphasizes the critical importance of meticulous clinical trial design. "We worry incessantly about clinical trial design because it has to be right. It's about creating robust, meaningful data that benefits patients, doctors, and businesses alike."
Currently, Orchestra is running a few large-scale studies involving hundreds of patients each. Their Backbeat program with Medtronic is a notable example. It’s designed to help people with cardiac pacemaker implants who also have uncontrolled hypertension. What's unique about it is that it's a true randomized double-blind study, which is not easy to execute in the medical device world.
Orchestra’s focus extends beyond regulatory approval; they are committed to creating a therapy that genuinely benefits patients, physicians, and businesses. They have full control of the study design, which empowers them to ensure that the trial aligns with these broader objectives.
In David’s words, “We're not done just because we got to a regulatory milestone. We have to care about not just data good enough for approval, but data good enough to guarantee that this is really something that is good for patients, good for doctors, and good for business.” He understands the pitfalls of short-term decision-making and the allure of cutting corners to move quickly, so David stresses that one needs to stay on course, even when the journey is long and challenging.
In the grand scheme of things, Orchestra envisions not only improving healthcare but also reaping the rewards of their efforts. They anticipate earning royalties from every device that Medtronic sells with their therapy. Given that over a million patients worldwide receive pacemakers each year, and an estimated 70% of them also suffer from hypertension, this revenue stream holds immense promise. This is attributed, in large part, to their steadfast commitment to generating meaningful data that substantiates their therapy.
Thinking Long-Term Pays Off
One of the key lessons that David imparts is the importance of maintaining a long-term perspective. Some short-term decisions may seem necessary to reach immediate milestones. However, “Cutting corners is going to come back to haunt you, ” David emphasizes.
The traditional venture model is focused on investments resulting in a short- to medium-term exit. David's vision extends beyond that and recognizes that significant value can continue to accrue after a potential exit. By embracing revenue-sharing models, Orchestra seeks to capture a more substantial portion of this long-term value, ultimately delivering greater returns and creating lasting revenue for its shareholders.
One other area where long-term thinking is crucial is when it comes to clinical affairs. David shares, “There are short-term decisions that you can't undo. Making hasty choices in clinical trial design, prematurely sharing information, or rushing the commercialization of a product in an attempt to meet revenue milestones can have lasting consequences.” The goal is not just regulatory approval but generating robust, meaningful data that benefits patients, physicians, and businesses alike.
Five years into its journey, Orchestra has achieved significant results and remains committed to realizing its vision of transforming healthcare through creating value with its long-term partnerships.
Orchestra BioMed is paving a unique path in the medical device industry with its innovative and collaborative approach. Under the leadership of David Hochman, a veteran entrepreneur with a diverse background spanning decades, the company has struck a chord by creating high-impact medical devices and the collaborative infrastructure that makes it possible for more to come. David puts it this way, “Our model tries to break those barriers now. We're only going to win when you win."
David is an entrepreneur and venture capitalist with over two decades of experience who has dedicated his career to developing purpose-oriented medical devices. His enthusiasm for medtech innovation is nothing short of contagious.
After various roles in telecom and media — industries worlds apart from the life sciences — he delved into venture capital, focusing initially on biotech investments before shifting to medtech. “I was really driven by what we refer to as a double benefit. If we're going to make money and generate returns for investors, we're only going to do that because we've impacted patients and provided tools or solutions to care providers,” he recalls.
When David realized that medtech offered a unique opportunity to turn ideas into products and, subsequently, into profitable ventures, he helped co-found a company in interventional cardiology in the early 2000s, which allowed him to work closely with key opinion leaders in the field. “What drew me to medical device innovation, at least in the early days, was this perceived shorter cycle of both turning an idea into a product, as well as turning that work into a return on investment,” he explains.
However, the landscape of device innovation shifted significantly around 2008. Larger companies were no longer readily acquiring early-stage, pre-revenue startups. Plus, timelines were getting longer, largely driven by growingly complex clinical trials and more rigorous regulatory guidelines. All of these challenges required more capital and fueled David and his team’s determination to reevaluate their approach. Orchestra BioMed was born in 2018 in response to this, drawing inspiration from the biotech industry's partnership-driven model.
The vision of the company was to seek alignment with established global medtech strategics by setting up a collaborative structure that allowed them to share both risks and rewards. By supplementing the R&D capabilities of larger companies, Orchestra BioMed was able to bring innovative products to market more efficiently.
Orchestra is not just an investor or accelerator. It is an operating company with unique capabilities to drive research, development, and clinical trials. David takes pride in having assembled a team of seasoned executives, each averaging over 25 years of experience, who share a passion for their work.
As David puts it, they aspire to inspire the industry by demonstrating that alternative approaches can yield success. As Orchestra continues to grow and forge partnerships with industry giants like Medtronic and Terumo, David and his team are challenging traditional norms in the medtech industry. He says, “If we do our job well, we won't be the only people doing it this way. We're looking to be flattered by other people realizing this is the smart way to do things, rather than trying to do everything by themselves.”
Their two flagship products, BackBeat CNT and Virtue SAB were born from this collaborative spirit.
BackBeat CNT, also known as Atrioventricular Interval Modulation Therapy (A-V-I-M therapy), tackles a major global health issue: high blood pressure, affecting over a billion people worldwide. It's designed as an add-on for standard pacemakers, requiring no hardware changes. Instead, it uses the pacemaker's capabilities to control blood pressure and adjust the autonomic nervous system's responses. This is especially helpful for patients with both pacemakers and high blood pressure, which is quite common. BackBeat CNT has the potential to benefit millions of pacemaker patients, making it a significant advancement in cardiovascular care.
The second product, Virtue SAB, is designed to enhance angioplasty procedures. Unlike traditional drug-coated balloons, Virtue SAB uses a microporous balloon to deliver sirolimus, a proven anti-restenotic drug, directly to the target area. The design allows for precise drug delivery while eliminating the risk of drug-coating particulates. By ensuring the drug reaches the target area directly, Virtue SAB provides extended focal release of sirolimus over approximately 30 days.
Orchestra BioMed's flagship product, BackBeat CNT, has received full IDE (Investigational Device Exemption) approval from the FDA. While Virtue SAB has received conditional IDE approval, David’s team is actively looking to apply their model to more groundbreaking technologies.
Key Learnings From David’s Experience
- Embrace creativity in structuring partnerships and business models. The nature of collaboration depends on you and your partner organization’s vision, capabilities, and long-term goals. When done right, sharing risks and rewards can be highly productive.
- Having robust operational capabilities enables you to generate more clinically meaningful data. The more impactful the data, the more value you can build.
- Prioritize a long-term outlook over short-term gains. Do not cut corners in favor of reaching certain milestones, especially in clinical trials that ladder up to your regulatory strategy.
David Hockman, founder and CEO of Orchestra BioMed, has over two decades of experience in healthcare entrepreneurship, venture capital, and investment banking. He has a history of leading successful medical startups, including Orchestra Medical Ventures and Accelerated Technologies. As Chairman of Motus GI and former board member of Corbus Pharmaceuticals and PROLOR Biotech, David has been instrumental in advancing medical technologies, contributing to significant mergers & acquisitions, and many fundraising successes.
Partnerships With Shared Risks and Rewards
David's journey began with a noble goal: to create medical devices that generate profits while making a meaningful impact on society.
As the landscape evolved, David skillfully borrowed and adapted the risk- and reward-sharing concept from the biotech industry, reshaping it for medtech. It’s the main principle Orchestra BioMed operates on.
What sets Orchestra apart from other medtech companies is its collaborative business model. They are not investors, nor an accelerator. David says, “We're going to be an operating business that has the ability to execute research and development and clinical programs.” They are breaking down barriers that often exist in discussions with large strategics. Instead of the traditional stilted conversations centered around potential acquisitions, Orchestra looks for ways to collaborate long-term.
Orchestra’s programs are wholly-owned subsidiaries of the company. They meticulously structure each one, complete with legal, financial, and operational frameworks. A joint steering body ensures the alignment of interests, facilitating efficient decision-making. Each program is unique and requires the Orchestra team to tailor their approach for optimal flexibility.
Their partnership with Medtronic, for example, has proven to be quite successful. The AVIM technology has been adeptly integrated into Medtronic's pacemaker devices after thorough testing. “We worked with them very carefully to design the trial that we got the approval for, and the partnership has the potential to expand to other indications," David explains.
Forming win-win partnerships should be the goal, but it's essential to weigh all factors before joining forces with another company. A well-thought-out collaboration can be very productive, but others can be risky.
David summarizes: "It wasn't easy to put together, but I will say it's going really well — we've accomplished a lot in a year, and we're excited about what we'll accomplish over the next couple of years and so on."
Meaningful Data Should Steer the Wheel
The robust infrastructure Orchestra has built with its networks makes it capable of conducting research, development, and clinical trials very efficiently.
David emphasizes the critical importance of meticulous clinical trial design. "We worry incessantly about clinical trial design because it has to be right. It's about creating robust, meaningful data that benefits patients, doctors, and businesses alike."
Currently, Orchestra is running a few large-scale studies involving hundreds of patients each. Their Backbeat program with Medtronic is a notable example. It’s designed to help people with cardiac pacemaker implants who also have uncontrolled hypertension. What's unique about it is that it's a true randomized double-blind study, which is not easy to execute in the medical device world.
Orchestra’s focus extends beyond regulatory approval; they are committed to creating a therapy that genuinely benefits patients, physicians, and businesses. They have full control of the study design, which empowers them to ensure that the trial aligns with these broader objectives.
In David’s words, “We're not done just because we got to a regulatory milestone. We have to care about not just data good enough for approval, but data good enough to guarantee that this is really something that is good for patients, good for doctors, and good for business.” He understands the pitfalls of short-term decision-making and the allure of cutting corners to move quickly, so David stresses that one needs to stay on course, even when the journey is long and challenging.
In the grand scheme of things, Orchestra envisions not only improving healthcare but also reaping the rewards of their efforts. They anticipate earning royalties from every device that Medtronic sells with their therapy. Given that over a million patients worldwide receive pacemakers each year, and an estimated 70% of them also suffer from hypertension, this revenue stream holds immense promise. This is attributed, in large part, to their steadfast commitment to generating meaningful data that substantiates their therapy.
Thinking Long-Term Pays Off
One of the key lessons that David imparts is the importance of maintaining a long-term perspective. Some short-term decisions may seem necessary to reach immediate milestones. However, “Cutting corners is going to come back to haunt you, ” David emphasizes.
The traditional venture model is focused on investments resulting in a short- to medium-term exit. David's vision extends beyond that and recognizes that significant value can continue to accrue after a potential exit. By embracing revenue-sharing models, Orchestra seeks to capture a more substantial portion of this long-term value, ultimately delivering greater returns and creating lasting revenue for its shareholders.
One other area where long-term thinking is crucial is when it comes to clinical affairs. David shares, “There are short-term decisions that you can't undo. Making hasty choices in clinical trial design, prematurely sharing information, or rushing the commercialization of a product in an attempt to meet revenue milestones can have lasting consequences.” The goal is not just regulatory approval but generating robust, meaningful data that benefits patients, physicians, and businesses alike.
Five years into its journey, Orchestra has achieved significant results and remains committed to realizing its vision of transforming healthcare through creating value with its long-term partnerships.
