An Unorthodox Path to Medical Device Success

Interview with Cresilon CEO Joe Landolina

Innovation is second nature to Joe Landolina. As someone who grew up in an environment that fostered curiosity and learning, with a grandfather who ran a chemistry lab, it’s no surprise that Joe invented the technology of Cresilon’s flagship product Vetigel at the youthful age of 17.

Concerned about lab safety, Joe's parents encouraged him to pursue a formal research education. As a result, he had the unique opportunity to spend a summer learning about tissue engineering at Columbia University as a high school student, understanding how to use plant-based skills to differentiate stem cells into a target tissue.

As an incoming freshman at NYU's School of Engineering, Joe discovered a unique material derived from algae that could instantly reassemble, adhere to the skin, and stay put until removed. This led to his novel idea: what if this material could be injected into an active trauma site, such as a bullet wound, to stop the bleeding and stabilize the patient until they could reach a higher level of care?

While Joe would go on to refine the technology and its application beyond his initial idea, this discovery was the genesis of Vetigel and the foundation for Cresilon.

Today, Cresilon is a testament to Joe's enduring curiosity and drive for discovery. In its simplest form, the company’s flagship product, Vetigel, can stop even the most severe, pulsating arterial bleeding within seconds by creating an immediate mechanical barrier.

Vetigel creates a near-perfect mechanical sealant, but its true uniqueness lies in its ability to allow the patient to form their own fibrin patch underneath the gel. This means that once the gel is removed, the injury underneath heals naturally, with partially rebuilt vascular structures.

At present, Joe and his team are exploring the potential applications of this groundbreaking technology, pushing the boundaries of what's possible in the field of trauma care.

Key Learnings From Joe’s Experience

  • Having a solid strategy is key when exploring unorthodox approaches in the medtech industry. You need to reassess the market needs and your next steps continuously, stay vigilant to seize opportunities, and be flexible to pivot when necessary.
  • The FDA regulatory process isn’t always straightforward, and can sometimes seem like a black box. For that reason, make sure you nail the fundamentals before getting too creative and surround yourself with an experienced regulatory team to de-risk every step along your  journey.
  • Be cognizant of communicating your company’s narrative in a clear, succinct fashion. To do that, decide what your ultimate mission will be and simplify the complex jargon to help your audience understand your product and the value it brings. This approach attracts not only customers, but also potential investors and partners. 
Guest
Joe Landolina
CEO of Cresilon

Joe Landolina was introduced to chemical lab research at a young age, which kindled a lifelong interest in discovering responsive, nature-derived materials. Embarking on his journey as an entrepreneur and innovator at only 17, Joe invented the technology behind Vetigel, a major breakthrough in the field of trauma care. As the co-founder and CEO of Cresilon, Joe continues to push medtech frontiers with his unwavering commitment to innovation.

Building the Ship as You Sail

Joe’s journey to founding Cresilon was far from a cakewalk, and their inflection point as a company came about in an interesting way. Namely, a friend of Joe's, who was working at the Wildlife Conservation Society, told him they were struggling to treat the injured animals in the wake of Hurricane Sandy in 2012 due to limited access to hemostatics. Recognizing the pressing need and potential opportunity, Joe seized the moment, establishing the company’s initial focus on animal health. 

This approach came with several advantages. Joe recalls, “We realized really quickly that animal health was unique because the regulatory barrier to entry is lower and there are no specific veterinary device regulations, so we took the human device equivalent.” This strategic direction proved to be instrumental in generating revenue long before their human-use applications were developed.

Another decision Joe made was to go down the path of verticalization. He explains that although it’s a common practice to outsource early-stage design and manufacturing to contract firms, it’s not always the best option. 

Cresilon intended to develop highly specialized formulations, such as stem cell tissue engineering and scaffolding. These solutions demanded equally specialized manufacturing processes with a steep learning curve. In Cresilon’s case, outsourcing their production wasn’t viable as it wouldn’t have given them the wiggle room needed for early-stage development.

Therefore, instead of partnering with a contract manufacturer, Joe found it more practical for Cresilon to undertake full responsibility, steering toward verticalization.

This wasn’t an easy decision and it required substantial capital, which can be detrimental, especially during the early days of a startup. Although Joe doesn’t advise other entrepreneurs to tread the same path — unless there’s an absolute necessity — he concedes that Cresilon is now in a far better position than if they had taken a traditional approach. He recalls, “I think the engineer in me enjoys having control over not only the R&D and the manufacturing, but also the clinical communication because as you get feedback, you can use that to modify all of the pieces of the business.”

Today, Cresilon has submitted for 510(k) clearance, and the team is excited to treat their first human patients. The company has also partnered up with Walter Reed National Military Medical Center for the treatment of Penetrating Ballistic-Like Brain Injuries (PBBIs), a critical medical issue military personnel often face.

The Importance of Strategy and Teamwork in Balancing Regulatory Risks

To successfully chart a path through the complexities of the regulatory waters, Joe leans heavily on strategic planning, risk distribution, and a balanced team. He candidly acknowledges the inherent uncertainties when engaging with FDA, especially with innovative technology.

Cresilon's product is regulated as a medical device due to its polymer composition, a material that’s extensively used in the medtech industry. 

However, Cresilon’s journey with FDA hasn’t always been smooth. He says that most regulatory delays happen due to miscommunication when working with third parties, including Contract Research Organizations (CROs), consultants, and lawyers.

In his words, "The key thing we've learned and done an okay job at is realizing that the biggest X factor that comes into any FDA submission is not necessarily the FDA. It's not the company or the technology. It's where you have to bring in third parties." 

He emphasizes the importance of understanding this up front, having backup plans, and distributing risk across multiple areas to avoid major delays, favoring a “fundamental-driven strategy rather than a growth-driven strategy.”

Joe’s approach to navigating this landscape is employing a balanced team, both within the company and with external consultants. His magic formula is pairing maverick consultants, who are experienced and comfortable with pushing boundaries, with more conservative consultants who know the regulatory rules by heart. 

This combination often leads to creative yet workable solutions, straddling the line between risk and compliance. Joe applies a similar strategy when selecting CROs, preferring large, robust organizations for safety testing but engaging smaller, innovative groups when exploring alternative approaches. He adds, “It may not be the most capital-efficient approach, but if it ends up with the best result and the safest, most efficacious product, then in my opinion, it's worth it.”

It’s Critical That You Communicate a Clear Message

The life science industry can be highly complex. It's paramount that you distill your mission into something that the general public can easily understand. In other words, make sure you avoid complicated jargon or explanations that require people to jump through mental hoops to internalize.

For example, Cresilon has managed to encapsulate its product in a bite-sized, 22-second GIF that effectively communicates what they do. This doesn't just help with brand awareness, it also aids in raising capital, finding customers, and attracting potential partners. In Joe’s case, it landed Cresilon a huge partnership with Walter Reed.

The collaboration came about in a serendipitous manner. A researcher at Walter Reed saw Joe's interview on late-night TV, found Cresilon's work interesting, and reached out to him the next day. The duo then explored a new application for Cresilon's technology beyond its core competency of hemostasis. Now, Cresilon is developing a product to treat Penetrating Ballistic-Like Brain Injuries (PBBIs), such as gunshot wounds or shrapnel injuries to the brain. 

While still in its preliminary stages, this new application could represent a paradigm shift in the treatment of PBBIs and may become one of Cresilon's next commercial indications.

Download a copy of the interview transcript right here.
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Innovation is second nature to Joe Landolina. As someone who grew up in an environment that fostered curiosity and learning, with a grandfather who ran a chemistry lab, it’s no surprise that Joe invented the technology of Cresilon’s flagship product Vetigel at the youthful age of 17.

Concerned about lab safety, Joe's parents encouraged him to pursue a formal research education. As a result, he had the unique opportunity to spend a summer learning about tissue engineering at Columbia University as a high school student, understanding how to use plant-based skills to differentiate stem cells into a target tissue.

As an incoming freshman at NYU's School of Engineering, Joe discovered a unique material derived from algae that could instantly reassemble, adhere to the skin, and stay put until removed. This led to his novel idea: what if this material could be injected into an active trauma site, such as a bullet wound, to stop the bleeding and stabilize the patient until they could reach a higher level of care?

While Joe would go on to refine the technology and its application beyond his initial idea, this discovery was the genesis of Vetigel and the foundation for Cresilon.

Today, Cresilon is a testament to Joe's enduring curiosity and drive for discovery. In its simplest form, the company’s flagship product, Vetigel, can stop even the most severe, pulsating arterial bleeding within seconds by creating an immediate mechanical barrier.

Vetigel creates a near-perfect mechanical sealant, but its true uniqueness lies in its ability to allow the patient to form their own fibrin patch underneath the gel. This means that once the gel is removed, the injury underneath heals naturally, with partially rebuilt vascular structures.

At present, Joe and his team are exploring the potential applications of this groundbreaking technology, pushing the boundaries of what's possible in the field of trauma care.

Key Learnings From Joe’s Experience

  • Having a solid strategy is key when exploring unorthodox approaches in the medtech industry. You need to reassess the market needs and your next steps continuously, stay vigilant to seize opportunities, and be flexible to pivot when necessary.
  • The FDA regulatory process isn’t always straightforward, and can sometimes seem like a black box. For that reason, make sure you nail the fundamentals before getting too creative and surround yourself with an experienced regulatory team to de-risk every step along your  journey.
  • Be cognizant of communicating your company’s narrative in a clear, succinct fashion. To do that, decide what your ultimate mission will be and simplify the complex jargon to help your audience understand your product and the value it brings. This approach attracts not only customers, but also potential investors and partners. 
Guest
Joe Landolina
CEO of Cresilon

Joe Landolina was introduced to chemical lab research at a young age, which kindled a lifelong interest in discovering responsive, nature-derived materials. Embarking on his journey as an entrepreneur and innovator at only 17, Joe invented the technology behind Vetigel, a major breakthrough in the field of trauma care. As the co-founder and CEO of Cresilon, Joe continues to push medtech frontiers with his unwavering commitment to innovation.

Building the Ship as You Sail

Joe’s journey to founding Cresilon was far from a cakewalk, and their inflection point as a company came about in an interesting way. Namely, a friend of Joe's, who was working at the Wildlife Conservation Society, told him they were struggling to treat the injured animals in the wake of Hurricane Sandy in 2012 due to limited access to hemostatics. Recognizing the pressing need and potential opportunity, Joe seized the moment, establishing the company’s initial focus on animal health. 

This approach came with several advantages. Joe recalls, “We realized really quickly that animal health was unique because the regulatory barrier to entry is lower and there are no specific veterinary device regulations, so we took the human device equivalent.” This strategic direction proved to be instrumental in generating revenue long before their human-use applications were developed.

Another decision Joe made was to go down the path of verticalization. He explains that although it’s a common practice to outsource early-stage design and manufacturing to contract firms, it’s not always the best option. 

Cresilon intended to develop highly specialized formulations, such as stem cell tissue engineering and scaffolding. These solutions demanded equally specialized manufacturing processes with a steep learning curve. In Cresilon’s case, outsourcing their production wasn’t viable as it wouldn’t have given them the wiggle room needed for early-stage development.

Therefore, instead of partnering with a contract manufacturer, Joe found it more practical for Cresilon to undertake full responsibility, steering toward verticalization.

This wasn’t an easy decision and it required substantial capital, which can be detrimental, especially during the early days of a startup. Although Joe doesn’t advise other entrepreneurs to tread the same path — unless there’s an absolute necessity — he concedes that Cresilon is now in a far better position than if they had taken a traditional approach. He recalls, “I think the engineer in me enjoys having control over not only the R&D and the manufacturing, but also the clinical communication because as you get feedback, you can use that to modify all of the pieces of the business.”

Today, Cresilon has submitted for 510(k) clearance, and the team is excited to treat their first human patients. The company has also partnered up with Walter Reed National Military Medical Center for the treatment of Penetrating Ballistic-Like Brain Injuries (PBBIs), a critical medical issue military personnel often face.

The Importance of Strategy and Teamwork in Balancing Regulatory Risks

To successfully chart a path through the complexities of the regulatory waters, Joe leans heavily on strategic planning, risk distribution, and a balanced team. He candidly acknowledges the inherent uncertainties when engaging with FDA, especially with innovative technology.

Cresilon's product is regulated as a medical device due to its polymer composition, a material that’s extensively used in the medtech industry. 

However, Cresilon’s journey with FDA hasn’t always been smooth. He says that most regulatory delays happen due to miscommunication when working with third parties, including Contract Research Organizations (CROs), consultants, and lawyers.

In his words, "The key thing we've learned and done an okay job at is realizing that the biggest X factor that comes into any FDA submission is not necessarily the FDA. It's not the company or the technology. It's where you have to bring in third parties." 

He emphasizes the importance of understanding this up front, having backup plans, and distributing risk across multiple areas to avoid major delays, favoring a “fundamental-driven strategy rather than a growth-driven strategy.”

Joe’s approach to navigating this landscape is employing a balanced team, both within the company and with external consultants. His magic formula is pairing maverick consultants, who are experienced and comfortable with pushing boundaries, with more conservative consultants who know the regulatory rules by heart. 

This combination often leads to creative yet workable solutions, straddling the line between risk and compliance. Joe applies a similar strategy when selecting CROs, preferring large, robust organizations for safety testing but engaging smaller, innovative groups when exploring alternative approaches. He adds, “It may not be the most capital-efficient approach, but if it ends up with the best result and the safest, most efficacious product, then in my opinion, it's worth it.”

It’s Critical That You Communicate a Clear Message

The life science industry can be highly complex. It's paramount that you distill your mission into something that the general public can easily understand. In other words, make sure you avoid complicated jargon or explanations that require people to jump through mental hoops to internalize.

For example, Cresilon has managed to encapsulate its product in a bite-sized, 22-second GIF that effectively communicates what they do. This doesn't just help with brand awareness, it also aids in raising capital, finding customers, and attracting potential partners. In Joe’s case, it landed Cresilon a huge partnership with Walter Reed.

The collaboration came about in a serendipitous manner. A researcher at Walter Reed saw Joe's interview on late-night TV, found Cresilon's work interesting, and reached out to him the next day. The duo then explored a new application for Cresilon's technology beyond its core competency of hemostasis. Now, Cresilon is developing a product to treat Penetrating Ballistic-Like Brain Injuries (PBBIs), such as gunshot wounds or shrapnel injuries to the brain. 

While still in its preliminary stages, this new application could represent a paradigm shift in the treatment of PBBIs and may become one of Cresilon's next commercial indications.

Download a copy of the interview transcript right here.
Share:
Twitter
Facebook
LinkedIn
Email

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