EndoRx
Paving The Path From R&D to Commercial Triumph

Successful commercialization is the goal of every startup. Equipped with crucial R&D data, earlystage companies are at the forefront of ushering in a medical revolution. However, despite having solid R&D for an innovative product, taking an idea from the research and development stage to market success is a challenging task, especially in the medical device landscape.

EndoRx is a visionary medtech company that guides the scientific goals of startups into tangible market potential. EndoRx specializes in assisting early-stage businesses transition from the challenging R&D phase to a strategic exit.

Throughout this journey, startups need to clear crucial developmental milestones, not only to reach market success but also to build credibility in the eyes of potential strategic partners. Entering formal commercial development is a big hurdle these companies can struggle to overcome on their own, stemming from a lack of industry recognition and credible market presence.

EndoRx steps in with its fractional executive leadership approach, wherein it takes temporary managerial control of portions of the client’s business to help them chart out attainable goals and achieve critical milestones. It employs a holistic approach, taking into account which stage of development the client is in, and accordingly provides the necessary solutions that help them move forward. This includes facilitating third-party partnerships with vendors, collaborating with contract research organizations, engaging key opinion leaders (KOL), and using robust clinical trial management services to pave the way into the next developmental phase.

“As an integrator that bridges the gap to success for early-stage companies, our goal is to get clients ready for engagement with strategic partners,” says Christen Springs, Cofounder and Managing Partner at EndoRx.

Pioneering Breakthroughs in Cancer Care

Illustrating EndoRx’s proficiency in supporting startups is the adept management of a novel venture—a promising concept design called the MammoFlex that could provide nearunlimited scheduling flexibility for breast cancer surgery. After vetting the idea through its wide network of experts, EndoRx recognized its potential. It assumed an equity stake in the business that went on to become DFC Medical, with Springs taking the helm as General Manager

Despite the challenges posed by the COVID-19 pandemic and supply chain disruptions, EndoRx steered DFC Medical through the complex product development journey. The partnership has witnessed continued success, culminating in the full completion of the device program and receiving FDA clearance in Q4 2023. DFC plans to begin patient treatments in early 2024, launching the product through a partnership with a third-party distribution sales force that EndoRx recruited and will continue to manage. This marks a landmark milestone for any medical device company as it transitions from development to becoming a fully operational, qualitymanaged business prepared to treat patients.

The Art of Fractional Leadership

The success of DFC Medical stands as a testament to EndoRx’s approach to guiding startups to commercialization. Led by Springs and Dr. Isaac Raijman, the company is proficient in delivering comprehensive support to cater to the diverse needs of its clients. These may vary depending on the owner’s vision for their company. While some may first want to guide their device through the FDA and to market, others may want to focus on pre-commercial business development, partnership opportunities, and investor engagement.

EndoRx excels in catering to diverse startups, thanks to the extensive expertise of its managing partners.

Springs draws upon 20 years of medical device experience, 15 of which have been in senior leadership roles inside successful early-stage startup ventures. A relentless operator, he is no stranger to 12-hour days, engaged in project management across the company’s portfolio of five medical device development programs.

Dr. Raijman, a global thought leader in advanced endoscopy, serves as the Chief Medical Officer. Dr. Raijman leverages his relationship with a long list of KOLs to bring together a veritable think-tank of experts. Startups lacking KOL engagements benefit from EndoRx’s ability to assemble an international advisory board, as these experts provide valuable feedback on product design, development, and scientific insights to meet market demands. Demonstrating an unyielding determination to balance clinical responsibilities for clients, he swiftly overcomes challenges and strives to achieve positive outcomes for every project.

The fractional approach allows the pair to provide services across multiple businesses without being fulltime employees. It has proven to be a remarkably efficient and effective strategy; a level of project management expertise that is a rarity in the industry. Their combined industry expertise lends credence to the fractional approach, which is essentially a path to building credibility for the client.

The journey begins with a thorough audit of a client’s business to identify areas of strength, and where they can benefit from improvements. Whether lacking a clear plan of action, realistic goals, or the necessary personnel within their infrastructure to give them a boost, EndoRx bridges these gaps to ensure that clients are operating at full capacity.

We are well on track to start the clinical trials needed for approval by mid2024

It aligns with the client’s objectives and formulates a game plan. To steer the company’s operations in the right direction, Springs and Dr. Raijman step into various executive leadership roles. While Springs normally takes on a managerial position, Dr. Raijman oversees duties as a scientific advisory leader, giving clients access to expert management along with substantial design, development, and clinical trial proficiency from a scientific standpoint.

Innovative Partnerships for Startup Triumph

With the audit complete, and a gameplan in place, the next step is to take the client’s R&D into commercial manufacturing. This is where the strength of EndoRx’s holistic service becomes evident, stemming from an extensive network of partners that it has developed over seven years since the founding of the organization in 2015. EndoRx leverages these ‘vendor partners’ to offer a range of services essential for medical device production geared toward FDA approvals. These include device development and contract manufacturing, support during clinical trials, intellectual property and legal aid, quality system development and control, and market development field activities.

A key aspect of its services is helping startups transition from in-house production to industrialgrade manufacturing. This can be difficult to achieve on their own as contract organizations are normally hesitant to take on the risks of working with early-stage companies. EndoRx helps them overcome this hurdle by leveraging its extensive network of manufacturing partners and its history of working successfully with these groups.

Clients receive ample guidance in selecting the most suitable CROs for their specific projects and manufacturers are thoroughly vetted to ensure they can perform as advertised. But EndoRx does not stop at guidance as it actively manages the chosen contract manufacturer, ensuring the client reaps the full benefits of their expertise and established partnerships. This distinct capability of providing a multifaceted service allows EndoRx to support startups at various stages of commercialization and has been crucial to the success of its clients as they progress.

The final milestone on this journey, for most startups, is the acquisition by a strategic partner. Since most startup entrepreneurs look for a strategic exit after taking their product to market, EndoRx prepares owners and CEOs from the onset of their collaboration.

This includes developing the commercialization plan and allocating resources based on the intended exit strategy, which could involve building the device and design history file to seamlessly integrate into the quality system of potential acquirers.

EndoRx has built its reputation in the corporate business development community by navigating startups through the commercial development process to ensure that they have a clear pathway to approval and market entry. It assists clients in forming connections with such organizations as EndoRx shines in its strategic engagement with industry giants. It conducts quarterly meetings with major publicly traded companies within the medical device sector to provide continuous updates on the portfolio.

Connecting clients with strategic partners is a meticulous process for EndoRx as it understands that clients must “earn the right” to be in the room when discussing the possibility of a transaction. To help clients build credibility, it focuses on helping them achieve as many milestones as possible on the developmental journey. It fully aligns with client budgetary needs and excels at identifying likely strategics, recognizing that different organizations are attracted to different transaction ranges.

These partnerships are instrumental in facilitating EndoRx’s operations and were established through a history of successful business engagements. The first of these was the successful management of the company’s first medical device project from concept to FDA approval and an exit to ConMed, a pivotal moment that solidified the company’s reputation as a quality device development company.

A Catalyst for MedTech Innovation

In hindsight, the successful product delivery for the ConMed engagement was only a stepping stone in EndoRx's journey to becoming an industry leader. The device in question was The Rhino, the first biliary stone removal balloon with an expansion range of 9 to 22mm, which eliminated the need for size selection by conforming to a bile duct of any size. The product line was successfully marketed by EndoRx from its Houston-based office until ConMed acquired it in the spring of 2017.
EndoRx’s current portfolio includes names such as NovaScan, which is developing a real-time, ex vivo scanning system that can immediately test the presence of cancer from any biopsy sample at the press of a button. Novascan engaged EndoRx to manage the expansion of their technology into the Endoscopy space. EndoRx provided introductions, led the engagement with contract manufacturers, and facilitated the first clinical trial for the new endoscopic detection system. It now plays a prominent role in discussions with strategics across the GI community. Another notable client is AIWorks, a company pioneering an artificial intelligence solution that aids in providing guidance in taking biopsy samples of the bile duct during cholangioscopy procedures. EndoRx was engaged to manage the software platform through formal validation and FDA approval. “We are well on track to start the clinical trials needed for approval by mid-2024,” says Springs.

Successful partnerships like these contribute to EndoRx’s diverse but complementary portfolio strategy. By working with companies that complement each other clinically, EndoRx can more efficiently disperse resources across the entities. It recognizes that not all service providers are suited for every project and constantly seeks to diversify its offerings and build cross-functional relationships that can be flexibly applied to various projects. One of its new key initiatives revolves around establishing a market development division focused on pre-commercial KOL and industry engagement, clinical trial execution, and initial product launch.

EndoRx stands as a pillar of support for medtech startups, putting disruptive products on the map and guiding them on the road to market success.

Visit endorxmedical.com to know more about EndoRx’s innovative endoscopic technologies.