Squid Glaucoma hybridShunt (SGS)

The Squid Glaucoma hybridShunt (SGS) is a hybrid device that combines features of a glaucoma drainage device (GDD) and minimally invasive glaucoma surgery (MIGS) device. This is a joint project between The University of Texas Southwestern Medical Center and the Veterans Administration. This summary is non-confidential, and more information is available upon the signing of an NDA.

The proposed Squid Glaucoma hybridShunt is based on the architecture of the human collector channel-aqueous/episcleral venous system and will provide a slow and controlled release of AH through a much narrower tube compared to current GDDs [f =150 µm v. f=303 µm]. Aqueous humor release is further regulated by a 50 µm channel located between two enclosed chambers, reducing AH outflow, which minimizes inflammation, fibrosis, and other vision threatening complications while enabling the SGS to slowly reduce IOP.

The SGS is 90% smaller than current GDDs (11.7 vs 184 mm²), and require minimal surgical dissection compared to the incision needed for current GDDs (3 mm vs 10 mm), which eliminates the need for scleral/corneal patches. Additionally, we are proposing to develop a coating for the SGS with a novel solution, as part of our CDMRP application. This solution will also help in the reduction of surgery and AH induced inflammation.

Our proposed innovative approach in developing the SGS hybrid device leverages the advantage of biomimetic solutions and a design to address the key limitations of existing GDDs. By integrating advanced microfabrication techniques and flow-regulating structures inspired by natural AH outflow pathways, we aim to develop a next-generation device that minimizes surgical trauma, reduces fibrosis and inflammation, and enhances long-term functionality.

We submitted an NIH SBIR Phase I grant proposal (April 2025) with an anticipated start date of Q1 2026. We will be seeking SBIR Phase II support next year for development and commercialization, licensing opportunities with industry partners, and angel and family office funding to accelerate SGS development.

We have applied for a Department of Defense CDMRP grant ($3.5M), scheduled for application in July 2025 and execution in 2026. We are also seeking to develop drug delivery solutions as part of our CDMRP application. We have several solutions which we will test as part of the grant program.

We are targeting the glaucoma market that affects over 80 million patients worldwide, including 3.5 million in the USA, making it the second leading cause of blindness.  The global glaucoma surgery devices market size was estimated to reach $1.57 billion in 2022 and is estimated to increase at a compound annual growth rate (CAGR) of 4.61% during the forecast period.

The SGS will provide clinicians with an effective, reliable, and affordable solution to manage IOP in patients with glaucoma. Through our applications for SBIR Phase 1 grant and the CDMRP grant, our goal is to submit data for FDA 510(k) clearance as a Class II medical device.

We are seeking license and collaboration opportunities with industry players and Angel / VC groups.

Earle Hager

Managing Partner

The Neutrino Donut, LLC / Neutrino Donut Project One, LLC

Los Angeles / Austin / Omaha

+1 512-431-3940

ehager@neutrinodonut.com

www.neutrinodonut.com

IRONMAN – Intermediate-term Restoration Of NormalMyocardial Activity in NYHA IV

The technology is an endovascular non-arterial left ventricular assistance device to provide up to 10L/min of flow for intermediate and long-term use. The proposed IRONMAN device addresses these needs with a 30F self-centering transaortic catheter featuring an axial flow impeller capable of delivering up to 10 L/min. The device is powered by a subcutaneous generator in the right chest with wireless charging. The patent is licensed from Washington University in St. Louis and the Veteran’s Administration. There is a U.S. Patent Application No. 63/698,917 titled “Mechanical Cardiac Support Device and Methods of Using Same” filed September 25, 2024. There is an International Patent Application No. PCT/US2024/021079 titled “Mechanical Cardiac Support Device and Methods of Using Same” filed March 22, 2024 with priority to US Patent Application No. 63/491,585 filed March 22, 2023.

The implantation involves transseptal puncture and advancement of the device via the mitral and aortic valves, guided by imaging. This design leverages venous access to accommodate large-caliber catheters, reducing pump speed and shear stress, thereby enhancing durability and minimizing hemolysis. The intracorporeal approach eliminates the need for sternotomy and supports patient mobility. Initial prototypes developed using CFTurbo and modeled with Simerics CAD software required high speeds (30,000–50,000 rpm) to achieve target flow, prompting ongoing refinements to optimize hemodynamics and reduce shear.

Heart failure is a clinical syndrome characterized by inadequate cardiac output to meet the metabolic demands of vital organs. Patients often progress through various stages, with Stage C representing symptomatic heart failure and Stage D denoting end-stage disease. At Stage D of heart failure, symptoms significantly impair daily life and lead to recurrent hospitalizations despite optimal medical therapy. The prognosis for patients with Stage D heart failure is poor, with a median survival of less than two years. However, advanced therapies such as heart transplantation can extend survival to over 12 years. Durable mechanical circulatory support (MCS) devices like left ventricular assist devices (LVADs) serve as either destination therapy or a bridge to transplant. Unfortunately, many patients are ineligible for these interventions due to factors such as multiorgan failure, frailty, cardiac cachexia, or prior thoracic surgeries.

The Ironman device is intended to be a durable (yet reversible) support device that can be delivered via a catheter-based delivery, thus more tolerable in sicker patients. The device can be a destination therapy or a bridge to other advanced therapies allowing recovery / improvement in functional status of patients with advanced heart failure, which could allow them to become candidates for other advanced therapies including transplantation. This is currently an unmet need worldwide which the IronMan device can fill.

We are seeking an SBIR NIH FastTrack application for a January 2026 deadline. We will be exploring other grant options as well. We are also seeking license and collaboration opportunities with industry players and Angel / VC groups.

Earle Hager

Managing Partner

The Neutrino Donut, LLC / Neutrino Donut Heart Stent, LLC

Los Angeles / Austin / Omaha

+1 512-431-3940

ehager@neutrinodonut.com

www.neutrinodonut.com

The Neutrino Donut is a consultancy with a focus on technology commercialization. Our focus is on managing the development process for startups, understanding the use of grant processes, business development, and fundraising programs via Angel and Venture markets. We have worked with startups in all aspects of the development lifecycle. We have an extensive understanding of the ecosystems for universities, startups, grant programs, and global projects. We provide consulting services for partners as well as our own clients.

Earle Hager

Managing Partner

The Neutrino Donut, LLC

Los Angeles / Austin / Omaha

512-431-3940

www.neutrinodonut.com

2026 Senate Bill Aims to Rescue SBIR Program

https://lnkd.in/grHhfDtx

The nation’s premier small-business research grant programs remain in legislative limbo as lawmakers race to revive them before a fast-approaching funding deadline. The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs – a 40-year-old “America’s seed fund” that has fueled cutting-edge R&D at startups – authority expired on September 30, 2025 after Congress failed to reauthorize them(**). Now, with a potential government shutdown looming on January 30, lawmakers are scrambling for a breakthrough. A last-ditch compromise bill released/circulated as a draft in December by Senator Edward J. Markey, Democrat of Massachusetts, seeks to end the impasse with reforms meant to address the national security and accountability concerns raised by Senator Joni Ernst, Republican of Iowa, whose objections have stalled the programs’ renewal(**).

A Compromise Bill Targets Security and “SBIR Mills”

Mr. Markey’s draft legislation – titled the “SBIR/STTR Reauthorization Act of 2025” (which you can read in its entirety at the bottom of this post) – pairs a multi-year extension of the programs with a suite of new provisions designed to answer Ms. Ernst’s criticisms. Notably, it would eliminate the programs’ sunset clause, effectively making SBIR and STTR permanent unless Congress acts to end them. The draft would raise the SBIR set-aside from 3.2% to 7% by FY2032 (and STTR from 0.45% to 1%), though the schedule in the draft excludes NSF and NIH. That increase is intended to expand opportunities for small firms – a priority long sought by program champions – even as the bill tightens oversight to ensure those dollars are well spent.
hashtag#neutrinodonuthashtag#sbirhashtag#ernsthashtag#sttrhashtag#nih

Nebraska Business Innovation Act

https://www.linkedin.com/feed/update/urn:li:activity:7414792997810348033

Governor Pillen just unfroze and boosted BIA funding: $12M → $15M/year (link to the announcement in the comments).

The ROI data makes his decision a no-brainer
– $1 → $5.75 in private investment
– 1,108 jobs created (avg wage $67K)
– $517M annual economic impact

Invest Nebraska and the Greater Omaha Chamber made this happen — along with so many others (looking at you Laurel Oetken). So Omaha-Lincolnians (and all Nebraskans), let’s take a moment to celebrate.

And then get back to work: BIA is not just startup funding. It’s leverage. The UNeTech Institute companies have used BIA funds to:

🔬 Precision Syringe – BIA → FDA work → private Omaha investment
🫁 RespirAI Medical – BIA → matched international investment → made possible the $1M international collaboration with Right at Home (link in the comments)
💪 Impower Health Inc – BIA → matching national investors → pilots start this year!
🩺 University Medical Devices – BIA → critical seed round → MicroWash is now on the market!!

BIA doesn’t replace outside capital. It attracts it.

Investors (around the world) see BIA backing and think: “Nebraska’s government believes in this company. Maybe we should too.”

The $3M increase matters because it gives us more matches to make. But the strategy stays the same:

✅ Use BIA to de-risk
✅ Use de-risking to attract outside capital
✅ Use outside capital to scale beyond what Nebraska can fund alone

Huzzah for the advocacy. Huzzah for Invest Nebraska. Huzzah for the ecosystem.

Now let’s close some more rounds.

hashtag#Nebraska hashtag#BIA hashtag#StartupEcosystem hashtag#Innovation

Let’s Get Back to Work – A Proposal for NIH Applicants

https://www.linkedin.com/feed/update/urn:li:activity:7414750524253691905

The SBIR program will be reauthorized. We don’t know how / when / terms at this point. What we do know, is we need to be prepared when the program starts to move aggressively toward potential deadlines. April? Later? Preparation will be the key.

The Neutrino Donut (www.neutrinodonut.com) will review 5 commercialization plans for potential Phase 2 SBIR submissions for the NIH SBIR program at no charge. The Donut will select the 5 plans for a group of the first 20 submitted. Please PM me with your interest and further discussions.
Earle Hager
Managing Partner
The Neutrino Donut, LLC
Los Angeles / Austin / Omaha
512-431-3940
www.neutrinodonut.com

hashtag#neutrinodonut hashtag#sbir hashtag#medicaldevices hashtag#NIH hashtag#STTR hashtag#commercialization hashtag#grants