Quick answer
Senphonix, Inc. won a Small Business Innovation Research (SBIR) Phase I award from the National Institutes of Health through the National Heart, Lung, and Blood Institute (NHLBI). The grant funds clinical-environment testing of the software behind SleeveSense, a wearable sleeve for continuous, long-term vital signs monitoring, along with cloud and database scaling and cybersecurity work toward SOC 2 Type II readiness. It was the company's second federal research award in a matter of weeks, following an NSF STTR Phase I. BW&CO led funding strategy, proposal development, and compliance and submission on both awards.
At a glance
Client: Senphonix, Inc., a medical technology company with offices in Arizona and Minnesota
Technology: SleeveSense, an upper-arm wearable and software platform for continuous vital signs monitoring in and out of the hospital
Funder: National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI)
Program: NIH SBIR Phase I (Award R43HL184398)
Announced: October 13, 2026
What it funds: Clinical-environment software testing, cloud and database scaling, and SOC 2 Type II readiness work
BW&CO role: Funding strategy, proposal development and writing, compliance and submission
The problem SleeveSense is solving
In most hospitals, vital signs are still captured by hand, a few times per shift. Nurses can spend 20 percent or more of every shift taking and documenting vitals, time pulled away from patient care. Because the readings are episodic, a change in a patient's condition can go unseen between checks. After discharge, many patients are not monitored at all, which leaves a gap linked to costly, avoidable readmissions.
SleeveSense is a comfortable sleeve worn on the upper arm for long periods, in and out of the hospital. It is designed to deliver clinical-grade measurements, charges wirelessly, and does not need to be removed or handled. Data flows into the electronic health record during the hospital stay and after the patient goes home, and discharged patients can view their own vitals in a simple mobile app.
The business model is built to remove upfront risk for hospitals. Senphonix provides and manages the infrastructure and bills only when a sleeve is assigned to a patient, so there is no capital outlay and no cost for unused capacity.
Why a second federal award, and why NIH
Senphonix's first federal award, an NSF STTR Phase I executed with the University of Arizona, funds the wearable's wireless hardware and the software platform. That left a distinct set of questions a hospital buyer will ask before adoption: Does the software hold up in a clinical environment? Can it scale? Is it secure enough for a health system's data?
Those questions sit squarely in NIH's mission. NHLBI funds technology that improves heart, lung, and blood health, and continuous vitals monitoring speaks directly to earlier detection of patient deterioration. Studies have shown that measurable changes in vital signs often precede serious adverse events, sometimes by hours. An NIH SBIR Phase I let Senphonix fund the clinical readiness of its data platform without overlapping the NSF scope.
Taken together, the two awards move SleeveSense and its software from prototype toward clinical readiness, with each funder supporting a different part of the path.
The challenge
Two agencies, one technology. NIH and NSF can fund the same company, but each proposal must stand on its own and avoid duplicating the other's scope. The NIH aims had to be clearly separate from the NSF hardware and platform work.
Speaking to an NIH review panel. NIH reviewers score significance, investigators, innovation, approach, and environment. A software and infrastructure project had to be framed around clinical impact and patient outcomes, not just engineering.
Running in parallel. The NIH application was developed while the NSF STTR effort was moving, which put a premium on coordination, timelines, and a founding team with limited hours.
Regulatory context. SleeveSense is a device in development and not yet FDA cleared. The proposal had to show a credible path to clinical testing and a planned 510(k) without overstating where the product is today.
How BW&CO helped
Built the multi-agency funding strategy
BW&CO mapped which parts of the SleeveSense roadmap fit NSF and which fit NIH, then shaped the NIH project around clinical software readiness, scaling, and security. That kept the two awards complementary rather than competing.
Positioned the project for NHLBI
We framed the work around the clinical problem NHLBI cares about: patient deterioration that goes unseen between manual checks, and the monitoring gap after discharge. Market evidence from Senphonix's own national studies supported the significance case, including surveys in which 98 percent of nurses (n=402) and 94 percent of healthcare CFOs (n=457) indicated they would support adopting SleeveSense in their organizations.
Developed and wrote the proposal
BW&CO led proposal development and writing with the Senphonix team, translating technical plans for software testing, cloud infrastructure, and SOC 2 Type II readiness into aims, milestones, and an approach an NIH panel could evaluate.
Managed compliance and submission
BW&CO handled compliance and submission readiness, keeping forms, registrations, budget, and formatting aligned with NIH requirements so the founders could stay focused on the science and the business.
Kept the two pursuits coordinated
The same BW&CO team supported both the NSF and NIH efforts, which kept the story, scope boundaries, and timelines consistent across agencies.
The result
Senphonix received an NIH SBIR Phase I award from NHLBI, its second federal research grant in a matter of weeks. The funding is non-dilutive, so the company keeps its equity while it advances the platform. Senphonix has said it expects to begin a clinical study of SleeveSense in late 2026 or early 2027 and to pursue FDA 510(k) clearance following clinical testing.
The two federal awards add to a broader base of non-dilutive funding and partnership behind SleeveSense, including Microsoft, the Arizona Commerce Authority through the WearTech Applied Research Center, and the University of Arizona.
"The barrier has never really been the sensor; it's been building something hospitals can actually put to work," said Mike Haldane, Co-Founder and Co-CEO of Senphonix and principal investigator on the NIH award.
"Two federal research awards in a matter of weeks, on top of private and state support, and clear demand from the nurses and CFOs who would use and buy it, tells us the market sees what we see," said John Grant, PhD, Co-Founder and Co-CEO of Senphonix.
Read how the first award came together in our Senphonix NSF STTR Phase I case study.
Key takeaways for medtech and digital health founders
One technology can support more than one federal award. Split the roadmap into distinct, non-overlapping projects and match each to the agency whose mission fits it best.
Software and security work can be fundable. Clinical testing, scaling, and cybersecurity readiness are real adoption barriers. Framed around patient outcomes, they can make a strong NIH project.
Market evidence strengthens significance. Data from the people who will use and buy the product helps reviewers see why the work matters.
Coordination matters when pursuits overlap in time. Running parallel proposals with one team keeps scope, story, and deadlines aligned.
Frequently asked questions
Can a company receive NIH and NSF SBIR or STTR awards for the same technology?
Yes, as long as the projects do not duplicate each other. Each proposal needs its own distinct scope of work, and companies must disclose related pending and current support. Senphonix's NSF award funds the wearable's hardware and platform, while the NIH award funds clinical-environment software testing, scaling, and security readiness.
What is NHLBI and what does it fund through SBIR?
The National Heart, Lung, and Blood Institute is one of the institutes of the National Institutes of Health. Through the SBIR and STTR programs it funds small businesses developing technologies related to heart, lung, blood, and sleep health, including devices, diagnostics, and digital health tools.
Can NIH SBIR Phase I fund software and cybersecurity work for a medical device?
It can, when the work is research and development tied to health outcomes and fits the institute's mission. The key is framing aims around the clinical problem and the evidence needed to move toward adoption, not around routine product engineering.
Does a device need FDA clearance before applying for NIH SBIR funding?
No. NIH SBIR funds research and development, often well before a regulatory submission. A strong application shows a realistic path to clinical testing and regulatory clearance without overstating the product's current status.
What is the difference between NIH SBIR and NSF STTR?
SBIR lets the small business perform the research with an optional research institution partner. STTR requires a formal partnership with a research institution, with minimum shares of the work for both the company and the institution. NIH and NSF also review proposals against different criteria and missions.
How does BW&CO help with multi-agency funding strategies?
BW&CO reviews a company's technology, stage, and milestones, identifies which agencies and programs fit each part of the roadmap, and then supports proposal development, writing, compliance, and submission. Agencies make all award decisions.
Assess your funding path
If you are building a medical device or digital health platform and want to know which federal programs fit each part of your roadmap, talk with the BW&CO team. Schedule a funding fit call.
Program names are used for identification only. BW&CO is not affiliated with or endorsed by the sponsoring agencies. SleeveSense is a device in development and is not cleared or approved by the U.S. Food and Drug Administration. Results vary by program, company, and proposal; past results do not guarantee future awards.