Gentherm Medical Selects KNB Communications to Amplify News of its Groundbreaking Patient Warming and Securement Device

Gentherm (NASDAQ:THRM) named KNB Communications as agency of record to support the launch of the ThermAffyx™ Patient Safety System, a first-of-its-kind device integrating patient warming and securement for surgery.

Rhea-AI Summary

Gentherm (NASDAQ:THRM) named KNB Communications as agency of record to support the launch of the ThermAffyx™ Patient Safety System, a first-of-its-kind device integrating patient warming and securement for surgery. Gentherm submitted a 510(k) Class II premarket notification and expects FDA clearance in May 2026.

KNB will lead strategic healthcare communications to raise awareness among clinicians, investors, and patients ahead of anticipated regulatory clearance and commercial rollout.

Positive

• Integrated device combining patient warming and securement in one solution
• Agency of record appointment to KNB Communications to amplify launch
• 510(k) submitted for ThermAffyx with targeted FDA clearance in May 2026

Negative

• Commercial availability depends on FDA clearance expected in May 2026
• No financial, pricing, or commercialization timelines disclosed in the announcement

Argus Mar 10 session

-0.52% close to close Open Argus

Details

News Market Reaction – THRM

On Mar 10, the day this news came out, THRM closed 0.52% below the previous close.

Data tracked by StockTitan Argus for the Mar 10 session.

Key Figures

FDA submission type: 510(k) Class II premarket notification Expected FDA clearance timing: May

FDA submission type

510(k) Class II premarket notification

ThermAffyx Patient Safety System submission earlier this year

Expected FDA clearance timing

May

Anticipated clearance for ThermAffyx Patient Safety System

Historical Context

5 past events · Latest: Feb 19

5 events

1. Feb 19

   Earnings results

   24h Move

   +1.3%

   Record 2025 product revenue, solid cash flow and 2026–2027 guidance outlined.

2. Feb 05

   Earnings date set

   24h Move

   -1.0%

   Announced date and access details for Q4 and full-year 2025 results call.

3. Feb 03

   FDA submission

   24h Move

   -1.8%

   Filed 510(k) for ThermAffyx system with planned Q3 2026 market launch.

4. Jan 29

   Business combination

   24h Move

   -0.6%

   Announced Reverse Morris Trust with Modine Performance Technologies, highlighting synergies.

5. Nov 04

   Conference participation

   24h Move

   +0.5%

   Planned fireside chat at Baird Global Industrial Conference with webcast access.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

510(k), premarket notification, FDA

3 terms

510(k) regulatory

"Gentherm submitted a 510(k) Class II premarket notification to the FDA"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

premarket notification regulatory

"submitted a 510(k) Class II premarket notification to the FDA"

A premarket notification is a regulatory submission companies send to a health authority (for example, the U.S. Food and Drug Administration) to show a medical device is similar enough to an existing, approved product to be marketed. For investors, clearance from a premarket notification is like getting a green light to sell a product — it reduces regulatory uncertainty, shortens time to revenue, and lowers the risk that a new device will be blocked or delayed.

FDA regulatory

"premarket notification to the FDA for the ThermAffyx™ Patient Safety System"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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The PR agency was tapped for its deep healthcare communications expertise and will introduce the ThermAffyx™ Patient Safety System. 

STAMFORD, Conn., March 10, 2026 /PRNewswire/ -- Gentherm, the global market leader of innovative thermal management and pneumatic comfort technologies, and KNB Communications, an award-winning healthcare marketing and public relations agency, figuratively shook hands today when they jointly announced a partnership between the two companies.

As the official agency of record for Gentherm's medical division, KNB Communications will leverage its expertise in strategic communications and media relations to support the launch of Gentherm's innovative ThermAffyx™ Patient Safety System, a first-of-its-kind medical device designed to solve both the patient warming and patient securement challenge during surgery in a single, integrated solution. 

"ThermAffyx is a solution born of clinical need," explained Gentherm's Steve Fletcher, SVP & General Manager, Medical. "Surgeons identified Gentherm as a company that could design a product to improve patient safety. We recognized the impact of that story and chose KNB Communications for its ability to create and share compelling narratives."

Chintan Shah, President of KNB Communications, expressed his enthusiasm about the collaboration and noted its perfectly aligned with the agency's expertise in the medical device space. "At KNB Communications, we seek to partner with industry leaders announcing medical breakthroughs — from promising clinical trials to transformative technologies that improve patient safety. Our role is to translate complex science into clear, credible stories that help clinicians, investors, and patients understand why these innovations matter and how they shape the future of healthcare. ThermAffyx is the latest example, and we're proud to bring more awareness to Gentherm's market solutions," he said.

Gentherm submitted a 510(k) Class II premarket notification to the FDA for the ThermAffyx™ Patient Safety System earlier this year. FDA clearance is expected in May.

About Gentherm: Gentherm (NASDAQ: THRM) is a global market leader of innovative thermal management and pneumatic comfort technologies. Automotive products include Climate Control Seats (CCS®), Climate Control Interiors (CCI™), Lumbar and Massage Comfort Solutions, and Valve Systems. Medical products include patient temperature management systems. The Company is also developing a number of new technologies and products that will help enable improvements to existing products and to create new product applications for existing and new markets. Gentherm has more than 14,000 employees in facilities across 13 countries. In 2024, the company recorded annual sales of approximately $1.5 billion and secured $2.4 billion in automotive new business awards. For more information, go to www.gentherm.com.

About KNB Communications: Headquartered in Stamford, Connecticut, KNB Communications is an award-winning public relations and marketing agency specializing in the healthcare AI, life sciences, medical devices, and dental and health technology domains. The medical marketing and PR firm is widely recognized for developing creative, strategic, and impactful integrated campaigns. The KNB team is made up of media relations, social media, email marketing, content, website, digital marketing, and video experts.  

Media contact: Amy Roberts
aroberts@knbcomm.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/gentherm-medical-selects-knb-communications-to-amplify-news-of-its-groundbreaking-patient-warming-and-securement-device-302709655.html

SOURCE KNB Communications LLC

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Gentherm announcing about the ThermAffyx device (THRM) on March 10, 2026?

Gentherm appointed KNB Communications as agency of record to support ThermAffyx launch. According to Gentherm, KNB will handle strategic communications and media relations to raise awareness among clinicians, investors, and patients before commercial rollout.

Has Gentherm (THRM) received FDA clearance for ThermAffyx and when is it expected?

FDA clearance for ThermAffyx has not yet been granted; clearance is expected in May 2026. According to Gentherm, the company submitted a 510(k) Class II premarket notification earlier this year and targets a May decision.

What clinical or product problem does ThermAffyx (THRM) aim to solve for surgeons?

ThermAffyx integrates patient warming and securement to address both challenges in one device. According to Gentherm, the product was developed from clinical need to improve intraoperative patient safety and streamline surgical workflow.

How will KNB Communications support Gentherm (THRM) for the ThermAffyx launch?

KNB will apply healthcare communications and media relations expertise to promote ThermAffyx. According to Gentherm, the agency will translate technical science into clear narratives for clinicians, investors, and patients to build awareness.

Does the March 10, 2026 announcement for Gentherm (THRM) include commercialization dates or pricing for ThermAffyx?

The announcement does not provide pricing or concrete commercialization dates beyond anticipated clearance. According to Gentherm, the company disclosed a 510(k) submission and an expected May 2026 FDA clearance but gave no sales timetable.