Akeyna Founder Karen Cronholm Is “Moving the Needle Forward” on Safer Dermal Filler Procedures

How Akeyna Is Developing a Smart Needle for Safer Dermal Filler Injections

“We really hope it can help make procedures safer for patients, provide that peace of mind to injectors as well.” 

By-Hank Stolz
Photo- submitted

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Worcester, MA- On this edition of Aux Talks, Karen Cronholm, founder and CEO of Akeyna, discusses the company’s development of smart-needle technology designed to improve safety during dermal filler procedures.

“We like to say, ‘to move the needle forward,’” Cronholm said.

Akeyna is developing a light-based smart needle with biosensors located at its tip. The technology is designed to detect when a needle enters a blood vessel and alert the healthcare provider with a flashing light before the filler is injected.

The device addresses one of the most serious risks associated with dermal filler procedures: vascular occlusion. This can occur when filler is accidentally injected into or obstructs a blood vessel, potentially causing severe complications.

“If you do accidentally inject the filler into a blood vessel, it can cause some pretty devastating complications such as blindness, skin necrosis, even stroke,” Cronholm explained. “So, we really wanted to set out to solve this problem.”

Akeyna describes its proprietary technology as a real-time detection tool intended to help healthcare providers identify vascular risks during dermal filler injections. The product remains under development and is proceeding through the medical-device regulatory process.

Akeyna’s Experience in the Auxilium Accelerator

Akeyna was selected to participate in the first accelerator cohort at Auxilium, Worcester’s startup and innovation center.

Cronholm said the experience helped Akeyna make progress in several important areas, including:

• Solidifying the company’s FDA regulatory strategy
• Developing prototypes for planned human clinical trials
• Selecting a contract manufacturer
• Expanding the Akeyna team
• Strengthening its fundraising and commercialization plans

Auxilium provides early-stage companies with access to mentorship, workspace, business resources, training and potential investment as they develop and scale their ideas.

Cronholm discusses what it was like to become a member of Auxilium’s inaugural cohort and how the accelerator connected Akeyna with expertise and resources that would have been difficult for the company to access independently.

Building a Medical-Technology Company as a Female Founder

Cronholm also shares her experience as a female founder working in the medical-technology industry.

She discusses the challenges of raising capital, communicating the potential value of an emerging medical device and building relationships with investors, manufacturers, clinicians and regulatory experts.

Her advice to other entrepreneurs includes remaining focused on the problem they are trying to solve, listening to experienced advisers and continuing to build a strong network of people who can help move the business forward.

What Comes Next for Akeyna?

Over the next 12 to 18 months, Akeyna plans to continue advancing its prototypes, clinical research, regulatory strategy, manufacturing relationships and fundraising efforts.

The company’s larger goal is to make dermal filler procedures safer while giving both healthcare providers and patients greater confidence in treatment decisions and outcomes.

“I’m excited about helping patients. So, I think about that every day,” Cronholm said. “We really hope it can help make procedures safer for patients, provide that peace of mind to injectors as well.”

Listen to the complete edition of Aux Talks to hear more about Akeyna, Cronholm’s journey as a female medical-technology founder and the role Auxilium is playing in Worcester’s growing startup community.