Digital health · Allergy immunotherapy
Wyndly
A telehealth allergy practice that tests patients at home and ships physician prescribed sublingual immunotherapy to all 50 states. The custom drops at the center of the business are not an FDA approved product.
The kittens in Suffolk
In 2020 Aakash Shah moved back in with his family in Suffolk, Virginia. His sister had two kittens. He had a cat allergy he had spent his life avoiding rather than treating. Vacuuming did not help.
His cousin, Manan Shah, was an ear, nose and throat surgeon in Denver with a different answer for patients who did not want needles: allergen drops taken under the tongue at home. “What we want to do is fix your body, so it stops reacting to allergy triggers,” Aakash Shah later told Inc.
The pandemic made the rest obvious. If the evaluation could happen over video and the medicine could arrive in the mail, a practice that worked in one Colorado office could work in fifty. The cousins took that to Y Combinator and got into the Winter 2021 batch.
The line the whole business sits on
Allergen immunotherapy is old and well established. What the regulatory record says is narrower than the marketing around it. The FDA has licensed four sublingual allergen extract products in the United States, all tablets: Oralair for five northern grass pollens, Grastek for timothy grass, Ragwitek for short ragweed, and Odactra for house dust mite. Each treats one allergen category. There is no approved sublingual liquid.
The American Academy of Allergy, Asthma and Immunology states it without hedging: “There are currently no FDA-approved SLIT liquid (drops) formulations. The effectiveness of SLIT with U.S. allergen extract drops is still under investigation and the effectiveness of mixtures of allergens is not known.” The American College of Allergy, Asthma and Immunology tells patients that “Allergy drops are not FDA-approved and are off-label in the United States.”
The raw material is the same extract used for skin testing and allergy shots. Johns Hopkins Medicine draws the distinction precisely: “The FDA has long approved these extracts for allergy testing and shots, but they are not currently approved for SLIT.” A physician mixing that licensed extract into a patient specific drop is practicing off label. That is legal. It is also unapproved and not covered by most insurers.
The 2017 joint practice parameter from the two academies went further. Summary Statement 9 says that “Use of such products or formulations as prescribed SLIT therapy is currently off-label, at a practitioner's discretion and liability, and is without recommendation for any current particular indication in the US populations.” The task force graded that Strong, on evidence grade D.
The founders, and what each one said
Aakash Shah graduated from the University of Virginia in 2016 in computer science and cognitive science, then led growth engineering at SparkGift and Parse.ly. Manan Shah is a board certified otolaryngologist who, at the time of the 2023 round, was president of the Colorado Ear, Nose and Throat Society. He is chief medical officer and, in his cousin's account, owns what the company may and may not say.
In February 2021 TechCrunch reported the status accurately and attributed it to the physician: the drops are not FDA approved, and while they use the same medications approved for allergy shots, the compounded medication is not itself approved or regulated. In the same piece Manan Shah drew a boundary around food allergy the company still holds. “I just want to see a little more research and for the field to reach a consensus on safety,” he said.
Two years later the company's own funding announcement described immunotherapy as “a clinically-proven treatment approved by the FDA.” For the tablets that is true. For the compounded drops it is not. By 2025 the company's reference pages had corrected course, labelling drops as custom and tablets as FDA approved.
Thirty eight states, then fifty
In 2021 Wyndly reached 38 states through physician partnerships. It now says it serves all 50, updated November 2025, ages five and up, environmental allergies only.
The money model is cash pay by design: $99 a month billed annually or $110 billed quarterly, a $49.99 consult, and a $249 test or one billed to insurance when eligible. Aakash Shah told Inc. that insurance billing would have left patients paying about $200 a month out of pocket, so the company offered $100 without insurance instead. Growth came from answering allergy questions on Reddit and YouTube.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA authorizations held | None. No 510(k), PMA or biologics license under the company name, searched Sep 23, 2026. | Public record |
| What FDA has approved | Four sublingual tablets: Oralair, Grastek, Ragwitek, Odactra. Each covers one allergen category. No sublingual liquid is approved. | Public record |
| Society position | 2017 AAAAI and ACAAI practice parameter, Summary Statement 9: off label use of aqueous sublingual extracts is not endorsed. Strong recommendation, evidence grade D. | Public record |
| Evidence for the class | The 2013 JAMA systematic review graded the evidence moderate for aqueous sublingual immunotherapy in allergic rhinitis and asthma, with no anaphylaxis or death across the trials reviewed. Dosing in that literature is heterogeneous and largely non US. | Public record |
| Wyndly's own evidence | No registered trial. A PubMed search on Sep 23, 2026 returns nine records, and in every one the name appears only in an outside rhinologist's conflict of interest disclosure. No NIH or NSF award found. | Not found |
| A competitor's data | Curex published a 2,897 patient retrospective single arm cohort in Frontiers in Allergy on Jun 10, 2026, with no control group and Curex affiliated authors. Not a randomized trial. | Public record |
| How an investor described it | The Sweater Cashmere Fund told shareholders in its annual report for the year ended Mar 31, 2023 that “Wyndly Health, Inc. provides an FDA-approved medicine and telehealth, for allergy immunotherapy for the 50 million Americans suffering from severe allergies.” Compounded drops are not an FDA approved medicine. | Differs from the record |
| How the company described itself | Its Feb 2023 funding post called immunotherapy “a clinically-proven treatment approved by the FDA.” Its 2025 and 2026 pages separate custom drops from FDA approved tablets. | Claim changed over time |
| Scale | More than 60,000 patients, $1M revenue in 2022, sales doubled in 2024, 18 staff as of Aug 2025. | Company-stated |
Read plainly: the therapy class has real evidence behind it, graded moderate, mostly from European trials of formulations that are not what a US pharmacy compounds for one patient. Wyndly has added distribution, licensure across 50 states and a clear price, real gains in access. It has not added evidence, and the two academies that write the guidelines have declined to endorse the formulation it prescribes.
What to watch
- Whether Wyndly publishes patient outcomes. Curex has set a floor for what this category can put in the literature.
- Any registered trial. There is none today.
- Whether FDA licenses a broader sublingual product. Every approved tablet covers one allergen, which is the structural reason multi allergen patients end up with compounded drops.
- Whether the academies revise the 2017 parameter, which rests on evidence grade D and is nine years old.
In their words
“What we want to do is fix your body, so it stops reacting to allergy triggers.”
Aakash Shah, co-founder and CEO, Inc., 2025 · Interview
“Most people don’t realize there is this other option.”
Manan Shah, MD, co-founder and chief medical officer, TechCrunch, 2021 · Independent
“I just want to see a little more research and for the field to reach a consensus on safety.”
Manan Shah, MD, on food allergy, TechCrunch, 2021 · Independent
“The FDA has long approved these extracts for allergy testing and shots, but they are not currently approved for SLIT.”
Johns Hopkins Medicine, patient education, accessed 2026 · Independent
“Allergy drops are not FDA-approved and are off-label in the United States.”
American College of Allergy, Asthma and Immunology, patient guidance · Public record
“There are currently no FDA-approved SLIT liquid (drops) formulations. The effectiveness of SLIT with U.S. allergen extract drops is still under investigation and the effectiveness of mixtures of allergens is not known.”
American Academy of Allergy, Asthma and Immunology, conditions library · Public record
“Use of such products or formulations as prescribed SLIT therapy is currently off-label, at a practitioner's discretion and liability, and is without recommendation for any current particular indication in the US populations.”
AAAAI and ACAAI Joint Task Force practice parameter, 2017 · Public record
“We found that the evidence is of moderate strength overall and it supports the position that aqueous sublingual immunotherapy is associated with improvement in allergic rhinitis and asthma outcomes.”
Lin and colleagues, JAMA systematic review, 2013 · Public record
Related companies
Sources
- Public recordSublingual immunotherapy, a focused allergen immunotherapy practice parameter update
- Public recordSLIT Treatment for Allergic Rhinitis Nothing to Sneeze About
- Public recordSublingual immunotherapy patient guidance
- Public recordAllergen Extract Sublingual Tablets and GRASTEK product pages
- Public recordSublingual Immunotherapy for Allergic Rhinoconjunctivitis and Asthma, A Systematic Review
- Public recordPubMed search for Wyndly, nine records, all conflict of interest disclosures
- Public recordReal world outcomes of personalized sublingual immunotherapy via telemedicine
- Public recordAnnual reports on Form N-CSR, Sweater Cashmere Fund and Cashmere Fund
- Public recordQuarterly holdings on Form NPORT-P, sixteen filings
- IndependentSublingual Immunotherapy, Allergy Drops
- IndependentWyndly aims to bring allergy drops to the masses
- InterviewHow Wyndly Grew a Multimillion-Dollar Allergy Business on Reddit and YouTube
- InterviewTurning the Doctor’s Office Into a Digital Business
- CompanyAllergy care FAQ, pricing page and states we serve
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
