The following was provided while participating in the 2023 Destination Startup® Showcase.
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What We Do
Aspero Medical is enabling intraluminal endoscopic surgery through novel devices that improve access, stability, traction and precision instrument manipulation as part of the overall shift toward less invasive procedures, which have historically moved from open surgery to laparoscopic surgery and now are moving to intraluminal surgery (accessed through natural orifices).
Affiliated Institution: University of Colorado Boulder
Have we formed a company? Yes
Funding: Grant Funding, Direct/Indirect University Support, Angel Funding (including Self or Friends/Family), Venture Capital
Our Company and the Problem We Are Trying To Solve
Aspero Medical (Aspero) focuses on gastrointestinal (GI) diseases which affect approximately 70 million Americans annually. Aspero’s differentiated medical products for use in endoscopy procedures result in improved performance, saving time and money, and improved patient outcomes. In balloon endoscopy, the current smooth latex and silicone balloons used have a very low coefficient of friction, especially with the soft, mucous covered wall of the GI tract. This low friction regularly leads to balloon slippage, thus not allowing the scope to properly advance. Aspero’s micro-texturing technology, when applied to these balloons, dramatically increases friction and balloon anchoring, without increasing the safe pressure operating limit. This technology is designed to maximize anchoring while minimizing adhesion, thereby allowing more effective use of such balloon endoscopy technologies. The technology has been demonstrated in numerous animal procedures and extensive benchtop testing, showing a 3x improvement. Aspero’s product portfolio addresses the entire GI tract, and at nearly one million procedures annually in the US the total addressable market for Aspero’s products is $900M. There is a strong financial benefit for the patient, physician, and hospitals/clinics to use this technology. Aspero’s products for intraluminal endoscopic surgery are designed to: 1) reduce patient morbidity, 2) expand endoscopy’s use reducing surgery, 3) improve provider efficiency and profitability, and 4) reduce healthcare costs. Aspero’s technology is protected around two issued US patents, with multiple other patents pending. Aspero’s international patent strategy is focused on Japan and Western Europe.
Our Go-to-Market Strategy
Aspero is focused on the endoscopy market ($37 billion), of which 30% is accessories ($11 billion) with CAGR of 7%. Customers include all gastroenterologists as balloon endoscopy is expanding into all areas of upper/lower GI, including colonoscopy, small bowel, and gastric/esophageal. Gastroenterologists at all levels of care from teaching hospitals to low-income hospitals, and private practice endoscopy centers, are using these approaches, and all are in need of improved anchoring technology and additional tool access. Aspero will partner with regional distributors for initial sales and marketing. Aspero may also partner with Olympus or Fujifilm, or companies that are trying to get a stronger foothold into the balloon endoscopy market such as Boston Scientific or Medtronic – active dialogue is ongoing with these strategics. Aspero is also working with balloon and catheter manufacturers, such as Nordson Medical, to explore partnerships that could expand this micro-texturing technology beyond endoscopy. Developing cost-effective methods to manufacture balloon and catheters for a range of medical applications offers tremendous upside. Aspero’s go-to-market strategy includes a launch of multiple differentiated products over the next three years. Ancora SB, Aspero’s balloon overtube for small bowel enteroscopy, will launch under an NIH-funded comparative study in early 2023 after FDA 510(k) clearance. Ancora LB, an intraoperative split overtube, for endoscopic surgery in the large bowel is expected to launch in 2024, with a third product, for gastric and esophageal intraluminal endoscopic surgery (Ancora GE) to launch in 2025.
How We Will Generate Revenue
Aspero’s Ancora balloon overtubes are Class II medical devices with predicate and thus a 510(k) substantially equivalent application to the FDA. Aspero anticipates 510(k) clearance in early 2023 for the Ancora SB product. Aspero will launch the initial Ancora SB product offering through independent distributors throughout the US and other geographic markets. As the company expands the product line offering, to include the Ancora LB for broader large bowel applications, consideration will be given to a direct sales strategy. Aspero will stage the introduction and full market launch of Ancora SB immediately following receipt of the 510(k) clearance. The company intends to focus initially on a small subset of clinical experts within the field of small bowel gastrointestinal endoscopy procedures to develop centers of excellence and referral sites. These clinical champions and their sites may also be developed as training sites for courses on the use of Ancora SB balloon overtube. The company intends launch outside the U.S. market following the limited product launch period in the US and receipt of all regulatory clearances. The company envisions that Western Europe and Japan will be the initial targets for expansion. Aspero’s approach is to provide a superior product compared to current latex and silicon smooth balloons and balloon overtubes. Aspero targets ASP of $275 (same as current balloon overtubes in the market) with an 80% margin at scale for the Ancora SB product, with higher ASPs for the Ancora LB and Ancora GE product lines that include additional features and capabilities.
How We Will Benefit From Destination Startup®
Aspero is seeking $6M in a syndicated Series A raise to 1) move through commercial launch of the Ancora SB product and early sales to demonstrate uptake in 2023, 2) complete V&V testing and FDA submission of the Ancora LB, 3) followed by commercialization of the Ancora LB line. We see this Series A funding as potentially the last money in before projected profitability in 2025 or acquisition by a corporate strategic and exit. Aspero Medical is seeking primarily venture or corporate capital. Aspero has established strong relationships will multiple endoscopy strategics (Olympus, FujiFilm, Pentax, Medtronic) that are interested in strategic investment and distribution partnerships after FDA clearance of the Ancora SB product. Aspero will also be looking for additional team members in Q1 2023, and Destination Startup will be helpful in making those connections. To date, Aspero Medical has secured $1.1M in Series Seed equity funding, in addition to $4M in non-dilutive grant funding separate from University of Colorado research funds used to developed proof-of-concept and detail device designs. Aspero is continuing to submit NSF and NIH SBIR grants to fund additional product concepts that utilize core intellectual property and that address unmet clinical needs.
Aspero founders include Mark Rentschler (CEO) and Steven Edmundowicz (Chief Medical Officer). Mark (CU Boulder) is a recognized expert in medical mechatronics and device design, while Steven (CU Anschutz Medical Campus) is a former President of the American Society of Gastrointestinal Endoscopy (ASGE, 2019). The founding team is uniquely positioned for success, based on their collaborative history and experience in industry. Mark was previously senior engineer and director of operations for Virtual Incision and works regularly with medical device companies through his research lab, University coursework, and consulting. Steven is also actively involved in endoscopic device and procedure development with a number of medical startup companies. In 2020, Allison Lyle (Director of Engineering) and Jeff Castleberry (Chief Operating Officer) joined Aspero. Allison brings a decade of experience in bringing multiple devices through 510(k) to market and leads all engineering and manufacturing efforts at Aspero. Jeff brings decades of medical device startup experience to the team and leads operations including RA/QA with support from Evergreen Research. Primo Medical Group (Boston, MA) is Aspero’s contract manufacturer. Ania Camplin at Richtr Financial Studio serves as Aspero’s CFO. Aspero is supported by Wade Johnson and his Polsinelli IP team. Aspero has signed an exclusive IP license with CU. Aspero is continuing to grow relationships with established medical device companies including Olympus, FujiFilm, Pentax, Medtronic and Boston Scientific.