Meet a Founder: How Karen Cronholm Is Building Safer Aesthetic Injections at Akeyna

While Botox gets most of the attention in our modern culture of dermal aesthetic procedures, filler injections are incredibly common as well. There are an estimated 7.8 million filler injections performed annually, according to a 2024 report by the American Society of Plastic Surgeons. What many don’t realize is that patients are at risk of blindness or a stroke if a blood vessel is poked while giving the injection. It’s enough to keep any aesthetic injector up at night.

Karen Cronholm, co-founder and CEO of Akeyna, is working to change that. Akeyna has innovated a smart needle with a sensor embedded in its tip to alert the injector if they have poked a blood vessel before they push the plunger. It has incredible potential to increase the safety of the dermal aesthetics industry, and Akeyna has had eye-catching fundraising momentum this year.

Karen’s impressive leadership history includes Head of Field Marketing at EMD Millipore and most recently CEO of Cytrellis Biosystems. Her background in scaling life-science and medical device companies makes her exceptionally well-suited for building and accelerating Akeyna. I had the opportunity to talk with her about her journey with Akeyna, what she’s learned, and what makes the greater Boston area such a great place to build.

Startup Boston (SB): It can be hard for a founder to know when to fully commit to their startup. Given your background as a CEO in healthcare, can you walk me through how you came upon Akeyna and decided to pursue it full-time?

Karen Cronholm (KC): The idea for the technology was actually developed by my co-founder, Dr. Molly Wanner at MGH [Massachusetts General Hospital]. She's a full-time dermatologist who does research at the Wellman Center for photomedicine. She was the one who really identified this very clear clinical need for a better solution. I've actually been in the aesthetics industry for some time, so I was well aware of this issue facing the industry.

My background is in building and scaling life science products, specifically medical devices, for the past several years. So this combination that we had, of a strong unmet need and a differentiated technology that's also incredibly easy to use – that was just a clear conviction point for me.

Dr. Wanner and I were introduced by Dr. Rox Anderson, who is an inventor on the Akeyna patent and who I had worked with previously. Once Dr. Wanner and I started working together and validated the technical feasibility, we did a lot of market research, as well as talked to a lot of physicians to really establish the clear opportunity and demand for the product as well.

We did a survey where 92% of the injectors that we surveyed said they would purchase our product. So for me, committing full-time and then being able to accelerate the development of bringing the products to market, it really just made sense.

SB: It sounds like the data backed up your personal interest in the decision. Finding a cofounder is so important too, as we all know. The fact that you and Dr. Wanner were introduced and seemed to mesh so well is great. How does decision making go between you two?

KC: We heavily inform a lot of our decisions with customer input. I believe in getting a lot of information from our future customers, especially when it comes to the product design and how we’ll execute our clinical studies.

We're a startup so we do try to prioritize speed as well and make some pretty quick decisions.  We can do that because we're small and efficient. And certainly, we think about risk mitigation too.

When we're thinking about strategic decisions, strategic planning for instance, we really think about how we can mitigate risks to move the company forward. That helps with bringing investors on board as well.

SB: It’s clear that feedback and data are North Star here, as they should be. As a founder, what have you learned throughout your journey? Anything you wish you had known earlier?

KC:  I’ve learned so much. When I started as CEO of my last company, Cytrellis, we were already at the early clinical stage, and now I’m a co-founder at Akeyna where we’re starting from scratch, so of course it’s a little bit different.

Our device is a platform technology which is great, but that means you have to be focused. That's why we narrowed our first clinical application toward filler while we build to our broader vision for the technology. Making sure you have some balance towards all the things that you can do, while also being focused at the same time: that's something that you have to learn how to do pretty well as a founder. And that focus helps you be really efficient with where you spend the dollars that you're bringing in.

As a founder and a CEO, I think all the time about how we can make the best use of our funding that can get us to the next milestone, so that we can continue to raise more and build the business.

One more thing I’ll say is that at the early stage, especially in the medical device realm, a lot of companies may not be thinking about [reimbursement or] commercialization when they’re starting out. But you really do have to start with the end in mind and think about what the vision is and how you see it fitting into the marketplace. And that also helps you assess the opportunity at the same time.

Those are a couple of things that impact the core strategy of the business, and our decision making even on a day-to-day basis: making sure that we've set ourselves up for success by focusing on capital and thinking about commercialization. Even though that may seem very far away early on in the life of the company.

SB: I’ve seen that myself; investors really hesitate if you haven’t put some brain power to the a go-to-market strategy, even at the very early stage. Wrapping up here, what makes the greater Boston area the right place to build Akeyna?

KC: We're based just outside Boston, but I grew up in Lancaster. This whole Worcester- Greater Boston area is a great place for a medical device company - probably the best in the country to be honest, not to brag! (laughs) I do love it here and I think this region has a unique ecosystem that's ideally suited for Akeyna. We have direct access to a world class clinical institution like MGH, and Harvard through their connection with MGH.

And then, from an employee standpoint, there's this dense ecosystem here of all the Medtech talent. Many people don’t realize that there is a lot of manufacturing in Massachusetts, so that really helps when you're close to a contract manufacturer as well. We can partner with them better when we're physically closer.

The other thing that's great about this area is that there are really strong investor networks. There's this great community of life sciences innovation where we are that is unique, I think, to anywhere else in the country. I have a lot of engineers that work with me, so I think we have some of the best engineering talent here as well. The network is far-ranging.

SB: It’s true, the medtech community here has so much to offer! What’s next for Akeyna, or on deck for your future?

KC: We’ll be conducting our first in-human clinical studies this year which I'm really excited about. It’s a lot of work to bring that all together but just exciting to be at that point, and we're planning on gaining an FDA clearance in 2028.

What’s Next for Akeyna - and Why It Matters

As Akeyna moves toward its first in-human clinical studies and an anticipated FDA clearance in 2028, Karen Cronholm is building with the kind of discipline that defines strong founders: stay focused, use capital wisely, and keep the end customer in mind from day one.

Her journey is also a reminder of what makes Greater Boston such a powerful place to launch ambitious companies — world-class research institutions, deep technical talent, experienced operators, and an ecosystem willing to rally around innovation. If Akeyna’s momentum is any indication, this is one medtech startup worth watching closely.

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About the author: Linda Waller is the Founder & CEO of EPIGO.