Edulis Therapeutics

Our Vision

What if chronic GI patients could leave their routine scope exam with an out-of-sight, out-of-mind management option? Something purpose-built to treat the most stubborn of symptoms, avoid surgery, and last all the way till their next exam?

For the first time ever, Edulis is launching a private physician fundraising round. This is a unique opportunity to directly support and follow an innovative GI company's path-to-market where you'll receive exclusive updates on our testing progress and a real share of the business.

The Problem: doctors lack the tools for localized medicine in the GI tract.

GI doctors are uniquely ill-equipped when it comes to sustained, localized drug administration, oftentimes leaving patients with crude, mechanical interventions to manage their disease.

Our Solution: the world's first endoscopic drug implant system.

Edulis is revolutionizing GI care with the first line of first therapeutic implants for sustained, localized treatment of chronic GI conditions.

To accomplish this, we’ve developed a series of bioresorbable drug implants which are injected into the intestinal lining via a proprietary endoscopic syringe.

The result is a therapeutic payload which can be inserted during a routine endoscopy and last for up to 12 months as medication is released into the surrounding tissue.

With Edulis' localized delivery system, we can make existing medications safer and more effective, while potentially enabling new therapeutics for GI usage which previously struggled due to issues as systemic toxicity, gastric intolerance, or poor diffusion.

As much as we'd love to take credit, Edulis didn't invent this concept. We've seen implantable, parenteral drug depots succeed across the body: from ophthalmology implants for retinal diseases to subcutaneous hormone therapies. Products like Ozurdex, Nexplanon, Zoladex, and Sinuva have created a growing $25B+ market for sustained-release drug implants. Now, Edulis is pioneering this product vertical in the GI market.

Built by doctors, for doctors.

The Edulis implant system is a product of intense customer discovery, consisting of over 150 interviews with patients, physicians, insurers, hospital administrators, and more. These interviews led us to some important conclusions:

1. Scopes are the #1 tool for managing GI diseases, with over 24M procedures completed annually in the U.S. leading to over $100B+ in downstream care decisions. And yet, this fundamental GI tool is ignored when it came time for smarter drug administration. Both patients and doctors were leaving scope interactions unsatisfied.
2. Disease areas with localized phenotypes like Crohn's disease were top-of-mind for stakeholders. Patients frequently struggled with systemic side effects and immunogenicity when working traditional therapeutic regimens. There was a constant mental burden to find sustainable, non-surgical options, while expensive biologics weren't always approved.

We saw a clear opportunity to develop a patient-centric, long-term administration option for chronic patients, which leveraged patients' regular scope exams for targeted drug administration. Our first target: stricturing Crohn's disease.

Thanks to an early grant from the Crohn's & Colitis Foundation in 2023, we were able to complete our first pig study - showing that our unique endoscopic procedure was possible with a 24-hr implant retention demonstration.

Since then we've expanded our lead indication to encompass benign GI strictures, including anastomotic and esophageal strictures. Giving us a larger early market and easier path for clinical trial recruitment.

Our preclinical testing has improved as well...

We've now successfully tested our implants for up to three months in the GI tract with clean toxicology and no foreign body reaction.

In our latest testing, Edulis partnered with U.S. -based specialty manufacturers to produce our first professionally-made samples and establish a key supply chain for path to market.

Similar to a drug-eluting stent or prefilled syringe, Edulis' lead product would be regulated as a combination product. This refers to a medical product which contains both a drug and a device component, such as an endoscopic syringe paired with a bioresorbable drug depot.

While non-medical investors shy away combo products due to perceived regulatory complexity, they can offer several unique advantages for savvy investors...

1. Defensibility: parent companies are no longer reliant on hyper-specific formulation patents to ward off competition. They can own the procedure, not just the chemistry.
2. Platform technology: the best combo products are part of a platform. They represent a new "system" for clinical impact, often with a device facilitating numerous therapeutic applications. This gives them much higher exit value compared to something like a 510(k) device.
3. Partnership opportunities: combo products offer partnership and licensing opportunities with both drug and device companies. Doubling the pool of future acquirers.
4. Unique capabilities and differentiation: there is simply less competition in the combo product space and, by designing both sides of the product, you can achieve functions impossible for others.

Edulis is currently validating its platform with existing, proven therapeutic compounds. This both mitigates technical risk and expedites our regulatory journey with a 505(b)(2) -regulated implant before moving towards more novel, specialized APIs.

Edulis' lead product does not need to reach FDA approval in order to be bought or licensed by a strategic partner.

In fact, it's more likely for a partnership opportunity to be based on first-in-human data collected in the next three years. As 75% of medtech assets are sourced externally, it's become common for strategics to pursue companies early in their development. This is great news for early investors.

What kind of exits are possible for a company like Edulis?

Building a disruptive medtech business isn't easy, however the rewards can be substantial...

1. Guidant Corporation (acquired by Abbott for $4.1B)
2. IntersectENT (acquired by Medtronic for $1.1B)
3. BTG International (acquired by Boston Scientific for $4.2B)
4. Urogen Pharma ($1.2B, IPO)
5. Apollo Endosurgery (acquired by Boston Scientific for $615M)

Help us build the future of therapeutic endoscopy

Gastroenterologists rarely have the opportunity to be educated startup investors. In a world of AI deals at obscene valuations, this is a unique chance to skip the FOMO and be on the ground floor of GI innovation you can actually hold.

We have the team, the technology, and the early momentum. Now we need you.

Help us bring a new class of GI therapy to patients.