Hawthorne Health, Inc.

An Echocardiogram in Someone's Living Room

Somewhere in rural Georgia, a retired schoolteacher named Margaret sits on her sofa while a nurse named Keisha performs an echocardiogram on her chest. There is no hospital. No waiting room. No three-hour drive to the nearest research center. Margaret is enrolled in a cardiac valve study, and the study came to her.

This is a Tuesday for Hawthorne Health. Every week, across all 50 states, the company dispatches thousands of certified medical professionals - they call them Hawthorne Heroes - into homes, community pharmacies, churches, and shelters to run clinical trial visits. The patients stay put. The trial moves.

It sounds simple. It is the opposite of simple. The clinical trials industry spent decades building itself around centralized research hospitals. Hawthorne Health looked at that architecture and decided the whole thing needed to be inverted.

A Broken Architecture

Here is the uncomfortable math of clinical research in America: roughly 80% of clinical trials fail to meet enrollment timelines. Patient dropout rates hover around 30%. And the demographics of trial participants bear almost no resemblance to the demographics of the people who will eventually take the drugs being tested.

Black Americans make up 13% of the U.S. population but less than 5% of clinical trial participants. Hispanic Americans represent 19% of the population and less than 1% of trial enrollees. The data collected from these trials informs dosing, efficacy, and safety decisions for everyone - including the millions of patients who were never in the room when the data was generated.

The reason is not complicated. Most clinical trials are conducted at academic medical centers and large hospital systems concentrated in major metro areas. If you live in rural Appalachia or the Mississippi Delta, you might be four hours from the nearest trial site. If you work hourly, you cannot take three days off per month for study visits. If you do not speak English fluently, the intake process is bewildering. The system selects for proximity, privilege, and patience - and excludes everyone else.

Jodi Akin watched this problem from the inside. As Vice President of Global Clinical Affairs at Edwards Lifesciences, she led the pivotal trials that secured FDA approval for the SAPIEN transcatheter heart valve. She saw firsthand how the logistics of getting patients to research sites choked enrollment, killed diversity, and stretched timelines by months or years. The science was ready. The delivery infrastructure was not.

What If the Trial Came to You?

In 2015, Akin left Edwards and founded Hawthorne Effect Inc. - named, with some irony, after the psychological phenomenon where people behave differently when they know they are being observed. Her bet was structural, not technological: instead of building another app to streamline the existing system, she would build a parallel delivery network that bypassed the system entirely.

The concept borrowed from the gig economy. Hawthorne would recruit, vet, and train thousands of healthcare professionals - registered nurses, nurse practitioners, physician assistants, phlebotomists, cardiac sonographers - and deploy them on demand to wherever patients happened to live. A retired cardiologist in Boise could conduct a study visit at a patient's kitchen table in Twin Falls. A trained phlebotomist in Jackson, Mississippi could draw blood at a community pharmacy.

The early funding was modest: a $3.1 million seed round. Akin, an angel investor herself in over a dozen startups, knew that proving the model required real trial data, not a pitch deck. The company ran its first trials with a small network of Heroes, collecting data in the field under the same Good Clinical Practice (GCP) standards required at any major research hospital.

The Journey

Cloud, Heroes, and Community Sites

Hawthorne Health runs on three interlocking pieces. Together, they form something the clinical trials industry has never had: a decentralized trial execution engine with both the technology and the people to operate it at scale.

The platform covers eleven therapeutic areas: cardiovascular, dermatology, gastroenterology, immunology, infectious disease and vaccines, metabolic disorders, neurology, pediatrics, psychiatry, rare disease, and respiratory conditions. The breadth matters because decentralized trials are not a niche - they are the future operating model for all of clinical research.

Numbers That Actually Changed

In October 2023, Hawthorne announced recruitment results from the PREVUE-VALVE study on valvular heart disease. The data stopped people mid-sentence. The company had recruited over 1,000 patients across 48 states - with a 500-patient pilot completed in under four months - and the diversity numbers blew past every benchmark the industry had established.

The study used a single site of record model - one investigator overseeing distributed assessments performed by Hawthorne Heroes in the field. Patients did not have to be near a research hospital. They did not have to drive hours. They did not have to miss work. The barriers dropped, and the enrollment numbers reflected a country that clinical research had never seen before in its data.

Who's Paying Attention

In January 2024, Labcorp - the largest clinical laboratory company in the world - announced a strategic collaboration with Hawthorne Health. When a company that processes 2.5 million lab tests per day decides you are part of its future, the market tends to notice. The partnership focuses on advancing decentralized trial capabilities, increasing patient diversity, and reducing the operational burden on traditional research sites.

A year later, Hawthorne expanded again. In January 2025, the company partnered with RxE2, a pharmacist-led clinical trial services firm, to integrate community pharmacists into the Hawthorne network. The combined operation created what both companies described as the largest integrated community-based clinical trial network in existence.

In June 2025, the model proved out on the regulatory side when Hawthorne's in-home and community-based operational support contributed to the FDA clearance of Reflow Medical's Spur Peripheral Retrievable Stent System, tested through the DEEPER REVEAL trial. An FDA-cleared medical device, brought to market faster because trial visits happened in patients' communities instead of in hospital waiting rooms.

From Founder's Garage to Corporate Boardroom

Jodi Akin spent more than 30 years in the medical device and clinical research world before starting Hawthorne. At Edwards Lifesciences, she led the global clinical program that resulted in FDA approval of the SAPIEN transcatheter heart valve - one of the landmark approvals in interventional cardiology. She now serves as Founder and Chairman of the board.

In January 2024, the company brought in Josh Rose as CEO, a move that signaled Hawthorne's shift from startup to scale-up. Rose came with 14 years of executive experience at IQVIA and CVS Health, specializing in market strategy, M&A, and large-scale operations. The same month, three board members joined from Labcorp, CVS Health, and Northpond Ventures - Jon DiVincenzo, Tony Clapsis, and Ingo Chakravarty, respectively - adding more than 50 years of combined clinical trials and biotechnology expertise.

The executive team also expanded: Ricky de Lemos as Chief Operating Officer and Marc Leighton as Chief Product Officer. The message was clear. Hawthorne Health was no longer a plucky startup proving a concept. It was building the organizational muscle to operate as critical infrastructure for the pharmaceutical industry.

Back to the Living Room

Hawthorne Health's stated mission is plain: make clinical trials accessible and convenient for every patient and deliver meaningful, high-quality assessments for investigators. Its vision is broader - to improve clinical and commercial outcomes, advance medicine, and bring the patient-clinician relationship back home.

The competitive landscape includes well-funded players: Medable, Science 37, Curebase, and others building digital platforms for virtual and decentralized trials. Most of them lead with software. Hawthorne leads with people - and then wraps technology around them. The distinction matters because clinical trials involve needles, ultrasound probes, and structured neurological assessments. You cannot draw blood through an app. You cannot perform a cardiac echo over Zoom.

The company operates in a market that is shifting fast. The FDA has published multiple guidance documents encouraging decentralized trial designs. Pharmaceutical sponsors who watched enrollment crash during COVID-19 are now permanently rethinking their dependence on brick-and-mortar research sites. And the FDA's increasing focus on diversity action plans means sponsors need partners who can actually deliver diverse patient populations, not just promise them.

Back in Georgia, Keisha finishes the echocardiogram. The data uploads to the Hawthorne Cloud in real time. The principal investigator reviews it from her office in San Francisco. Margaret, the retired schoolteacher, asks when the next visit is. She does not have to clear her schedule or find a ride to a hospital three counties over. The visit will come to her again. Same sofa. Same nurse. Same study, running on time and on protocol.

One patient enrolled. One patient retained. One data point that actually represents the population it is supposed to serve. Multiply that by four thousand Heroes, fifty states, and seventy-six trials, and you start to see what Hawthorne Health is building: not a product, but a delivery network that makes clinical research work the way it was always supposed to.