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Drug delivery · Auto-injectors

Pirouette Pharma

A disk-shaped, push-button auto-injector built by three engineers who met running a student rocket lab, now paired with old drugs on abbreviated FDA pathways. Nine years in: US patents, a record crowdfunding following, and nothing on the market.

StartedDelaware, 2017 · YC Summer 2021
BasedPortsmouth, NH (was Arlington, MA)
ProductOnePush platform; REZQGO naloxone, QuicPush epinephrine
FDANo clearance, approval or listing on record, Sep 22, 2026
Federal grantsNIH NIDA SBIR R43DA059474, $479,080
CEOConor R. Cullinane, co-founder

The puck

Picked up cold, it does not read as a medical device. It is a flat disk roughly the size of a hockey puck. You twist off the cap, set it against a thigh or an arm, through clothing if you have to, and press a large button on the face. A needle you never see comes out, delivers the dose, retracts, and the device locks shut around it. The whole thing takes about two seconds.

That is the entire proposition. Pirouette calls the platform OnePush. The notes for a February 2026 Kingscrowd podcast put the ambition as turning the “violent, error-prone” experience of legacy auto-injectors into something nearer a “Staples Easy Button”.

Where injections actually fail

The argument is not about chemistry. Epinephrine and naloxone are decades old, cheap and thoroughly characterised. The failure happens in the seconds when a frightened person, often not the patient, has to use them.

Asked by Bio.News in June 2024 what it was fixing, Pirouette said: “A study with epinephrine auto-injectors showed that 14% of patients are so fearful that they won’t even attempt an injection, and 30% of injection attempts result in incorrect administration, such as accidental injections or lacerations.” It did not name the study.

Three friends from the Rocket Division

Conor Cullinane, Matthew Kane and Elijah Kapas met in 2010 at Clarkson University in Potsdam, New York, where they founded a student group called the Rocket Division and carried a rocket attitude control test bed through design, testing, manufacturing, funding and launch.

Cullinane took a PhD in medical engineering and medical physics at MIT and Harvard Medical School and worked on human factors and bioastronautics problems at NASA. Kane took a master’s in aerospace engineering at Notre Dame and runs operations and FDA interactions. Kapas runs the technology. All three are inventors on every Pirouette patent in the US record. The trigger was domestic: Cullinane grew up watching his brother carry an EpiPen, and what struck him was how little the object had changed.

A device company decides it is a drug company

Pirouette Medical Inc. was incorporated in Delaware in 2017 and filed its first Form D from Arlington, Massachusetts in July 2021, weeks after starting Y Combinator’s summer batch. By June 2022 the address was Portsmouth, New Hampshire, the state Cullinane grew up in. Then the name changed: one SEC registrant, CIK 0001870611, carries both Pirouette Medical Inc. and Pirouette Pharma Inc., and the April 2025 Form D was the first under the new one. Cullinane explained it to Kingscrowd in July 2025: a device paired with a drug is regulated as a pharmaceutical therapy, not a gadget.

That set the route. Pirouette says it is using the FDA’s 505(b)(2) and 351(k) pathways, which let a sponsor lean on existing data for a known molecule. Naloxone, branded REZQGO, and epinephrine, branded QuicPush, come first, with promethazine and methotrexate named as follow-ons and GLP-1s, oncology and immunology biologics described as partner territory.

The crowd showed up

In May 2024 Safar Partners led a round and the company threw the rest open to the public on Wefunder. That campaign closed in March 2025 at $7,953,327 on a $55 million valuation cap. Pirouette reopened in early 2026 at a $95 million cap and closed on March 27, 2026 at $4,979,659. Kingscrowd’s February 2026 market report named it that month’s largest Regulation Crowdfunding raise, at $3.32 million in February alone and 139.6% of its target maximum. As of September 22, 2026 the Wefunder page reports $12,680,159 from 4,906 investors and bills itself the “#1 most raised campaign in Wefunder history”.

The money bought a factory: a 10,000 square foot Portsmouth facility with an ISO Class 8 clean room, announced October 10, 2025. Pirouette now calls itself a “clinical-stage pharmaceutical company”.

What is proven, and what is still claimed

EvidenceWhat the record showsSource type
US patentsFive granted patents assigned to Pirouette Medical LLC or Inc.: 10,265,471 (Apr 2019), 10,441,714 (Oct 2019), 10,722,653 (Jul 2020), 11,324,882 (May 2022) and 12,011,569 (Jun 2024). Kapas, Kane and Cullinane are inventors on all five.Public record
Patent count as marketed21 awarded (May 2024), 22 worldwide (Dec 2024), 23 granted globally to 2045 (2026), said to span the US, Europe, China and Japan. Foreign grants do not show in the US index, so the counts are not comparable, and no list has been published.Unverified
FDA recordNo 510(k), PMA, device registration and listing, approved drug application or National Drug Code under either name in openFDA queries run Sep 22, 2026.Public record
FDA engagementCompany reports pre-submission meetings, a completed Type C meeting said to define an over the counter path, and an IND referenced in January 2026. FDA publishes neither, so none of it is checkable.Company-stated
Design already acceptedKingscrowd’s 2026 write-up repeats the company line that “its design was reviewed and approved by the FDA as is, without any additional device studies needed”. FDA does not approve a device design outside an application, and no application appears in the record.Differs from the record
Trials and papersNo study naming Pirouette as sponsor in a ClinicalTrials.gov query run Sep 22, 2026, and no PubMed hits. A pharmacokinetic study is described as planned.Not found
Federal grantsNIH NIDA SBIR R43DA059474, PI Conor R. Cullinane: $326,500 in FY2023 plus FY2024 supplements of $55,000 and $97,580. Total $479,080.Public record
Reliability claimsCompany cites 99.999% successful injection at 95% confidence. A 2024 investor newsletter on the same device cited 99.99%. No test report published.Company-stated
Preference researchCurrent materials cite 900 patients and 250 clinicians: 93% and 88% would switch, and “100% of oncologists would prescribe OnePush over current auto-injectors in blinded research study”. May 2024 gave 93% and 70%; December 2024 gave 90% and 75%. The research is unpublished.Figures differ
AwardREZQGO named 2024 Product of the Year by the New Hampshire Tech Alliance on Dec 11, 2024, by judge scoring plus a live audience vote against four finalists.Independent

Read plainly: the engineering and the patents are real and dated, the money is real and unusually well documented, and the regulatory story is entirely prospective. Every claim about FDA acceptance rests on private meetings. Every claim about patient preference rests on research the company has not released. What a reader can verify today is five US patents, one NIH grant line, five Form D filings and a factory in New Hampshire.

What to watch

  • An FDA record of any kind under either name. The company has pointed at a first approval in 2027 since December 2024.
  • A registered pharmacokinetic study, the one the February 2026 podcast says the 505(b)(2) route turns on.
  • Whatever financing follows March 2026. Kingscrowd put monthly burn at $517,200 and runway at 3.1 months as of January 2026, against $0 revenue in FY2024.
  • A named partner. The Wefunder page says “Big pharma + an aerospace leader are in advanced talks to use OnePush across multiple medicines” and names neither.

In their words

“Growing up, I watched my brother carry an EpiPen for his severe allergies, and I realized how little the technology had advanced over the years.”

Conor Cullinane, co-founder and CEO, Kingscrowd, 2024 · Interview

“It could have been Pirouette Aerospace or Pirouette Defense, but we chose to endeavor to empower lives as advocates for patients.”

Conor Cullinane, Kingscrowd, 2024 · Interview

“As our product matured, it became clear we weren’t just a med device company.”

Conor Cullinane, on the rebrand, Kingscrowd, 2025 · Interview

“It really short-cycled the period between producing a device, testing that device, updating the design, and producing another device.”

Conor Cullinane, on manufacturing in house, Medsider, 2026 · Interview

“When you’re putting together how much capital you think you need, you need more.”

Conor Cullinane, on the community round, Medsider, 2026 · Interview

“Recognition as the NH Product of the Year is a reflection of the small, but mighty team at Pirouette, who just showed that we also punch way above our weight class.”

Conor Cullinane, NH Tech Alliance, December 2024 · Company statement

“This funding is a crucial step towards bringing our groundbreaking device to market, aiming to enable life-saving medications that are within easy reach of those in need.”

Matthew Kane, co-founder and COO, company release, May 2024 · Company release

“The thing that kills companies is standing still and this is not a team who under any amount of stress is going to stop working on this product.”

Surbhi Sarna, Y Combinator, on the company investor page · Investor, via company
Pirouette Pharma funding profile on HVCFHealthcare Venture Capital Fund

Related companies

Sources

  1. Public recordFive Form D filings, CIK 0001870611SEC EDGAR · 2021 to 2026
  2. Public recordNIH RePORTER, 1R43DA059474 and supplementsNIH NIDA · FY2023 to FY2024
  3. Public recordUS patents 10265471, 10441714, 10722653, 11324882, 12011569USPTO via Justia Patents
  4. Public recordopenFDA queries: 510(k), PMA, registration and listing, Drugs@FDA, NDCFDA · Sep 22, 2026
  5. Public recordClinicalTrials.gov query for Pirouette as sponsorNIH · Sep 22, 2026
  6. IndependentPirouette Medical’s auto-injector wins 2024 Product of the YearNH Business Review · Dec 20, 2024
  7. IndependentNIH Innovation Zone 2024: Pirouette Medical is innovating safer, easier auto-injectionsBio.News · Jun 26, 2024
  8. InterviewHow to Build a Community of InvestorsMedsider · Aug 24, 2026
  9. InterviewWhat Investors Want to Know: Pirouette MedicalKingscrowd · Oct 1, 2024
  10. InterviewFrom Med Device to Pharma: How Pirouette Is Reshaping Injectable CareKingscrowd · Jul 22, 2025
  11. IndependentPirouette Pharma on Wefunder 2026Kingscrowd · Feb 9, 2026
  12. IndependentFebruary 2026: A More Selective Month for Investment CrowdfundingKingscrowd · Mar 10, 2026
  13. IndependentAlumni Start-Up Poised For Success: Pirouette MedicalClarkson University · Feb 20, 2023
  14. CompanySafar Partners Leads Pirouette’s Investment Round with $5M+ RaisedBusiness Wire · May 7, 2024
  15. CompanyPirouette Pharma website and Wefunder campaign pageAccessed Sep 22, 2026

Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.