Follicle Thought Features StimuSIL’s Medical Device SAGA-001

Delaware, US; June 29th, 2023 

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Follicle Thought is pleased to announce a new company developing a treatment for androgenetic alopecia with an innovative technology. Unlike most other biotechs tackling the challenging field of hair regeneration, StimuSIL is a biomedical device company. Their team has created a completely new way to deliver photobiomodulation and incorporated it into a proprietary, patented hair regrowth device.

StimuSIL: Subdermally Injecting Lasers to Regenerate Hair

StimuSIL is the latest company to throw its hat into the AGA treatment ring. Unlike other companies, StimuSIL isn’t creating a medication, designing a stem cell therapy, or attempting hair cloning. Instead, its approach is actually very straightforward: StimuSIL has taken an existing technology – photobiomodulation – and modified it to be more effective. The team believes their patented tech will help people with AGA regrow hair and thinks it will remodel the hair loss industry as they want it to be used to enhance the effects of other treatments, too.

StimuSIL’s focus is on creating treatments for dermatological and aesthetic issues, with its primary indication focused on androgenetic alopecia. While the company’s website says they are still in the preclinical stage, Pablo and Ana Villalba, Co-Founders of StimuSIL, were kind enough to briefly speak to Follicle Thought about their company and new device. Co-Founder and Chairman Pablo Villalba revealed that they’ve recently launched their first clinical trial.

Photobiomodulation and Hair Loss

Photobiomodulation – also known by many other names including low-level light therapy, low-level laser therapy, laser hair therapy, cold laser therapy, and LLLT – have been used to support hair regrowth for over half a century. This is the science behind home devices which use laser diodes, LEDs, or a combination of the two to deliver red, low-level light to the scalp. 

Visible light therapy has been known to help treat conditions like wrinkles, acne, and even pain. When applied to a person’s head, photobiomodulation is thought to work by stimulating cells and prompting them to release enzymes and chemicals, like nitric oxide. The trouble is that these home-use devices for hair loss don’t seem to do much for many people. This is the main reason that Follicle Thought has not previously discussed LLLT devices on this site; as you know, we’re focused on innovations.

That’s where StimuSIL comes in. They theorized that the problem with photobiomodulation wasn’t with the technology itself, but its delivery. LLLT devices for AGA use a low energy, longer wavelength light in the visible range that’s able to stimulate tissues and cells without heating skin and causing damage. They’re safe and can be used at home with little risk to the user. Higher powered lasers are used in professional settings for exactly the opposite purpose – like promoting coagulation or performing surgical incisions.

StimuSIL decided to try delivering low energy, long wavelength light in a different way. Rather than creating a consumer device for home use, they created a tool that was meant to be used by clinicians. This inspired them to try something slightly different: applying photobiomodulation while simultaneously bypassing the skin’s melanin layer. 

When using conventional lasers, most of the light is blocked and lost due to the skin’s melanin layer. This is the main issue with existing laser hair therapy devices. Applying conventional low-level lasers to the scalp supports hair growth, but it results in minimal benefit to the hair follicle and little potential for hair regeneration. 

StimuSIL’s precision system allows light to reach the hair follicle directly. This allows the StimuSIL device, SAGA-001, to deliver 5 to 6 times as much power to produce the maximum possible beneficial effect without heating or burning the skin.

SAGA-001: Combining Subdermal Stimulation and Photobiomodulation 

StimuSIL’s medical device involves a handpiece with single-use cartridges. The treatments are meant to be applied by a trained medical or aesthetic professional at a clinic, with each treatment taking around 20 to 30 minutes. The current treatment plan suggests that patients go in every other week for 4 to 6 months, then once a month afterward.  

StimuSIL is aware of other therapies currently in development, and the combinatorial approach taken by many patients with AGA. The company hypothesizes that topicals could potentially be used on SAGA-001 non-treatment days. “We’ve recently seen some other interesting treatments popping up, like Kintor’s Pyrilutamide [KX-826] and Cassiopea’s Breezula. Both of these new drugs are DHT blockers – and we can certainly say that we did not design SAGA-001 to block dihydrotestosterone or any other androgen. But in our preclinical trials, when we reduced the serum DHT levels in some of our test groups by other means, SAGA treatments produced even better results,” said Pablo Villalba.

Pablo, who also personally experiences hair loss, added: “AGA causes hair loss in several ways. So in an ideal world – why not attack hair loss from multiple directions? Depending on the patient, doctors may recommend combining SAGA-001 treatments with minoxidil, newer topicals like KX-826 and Breezula, or even as a complement to enhance the results of hair transplants. Eventually, we’d like everyone to be able to customize their hair loss treatment to maximize effectiveness and results.

Who’s Behind StimuSIL?

StimuSIL is a venture launched by siblings, engineers, and Co-Founders Ana Villalba and Pablo Villalba. They’ve created the company alongside a highly specialized team of engineers, pharmaceutical executives, and doctors, including StimuSIL’s Chief Medical Officer, Dr. Scott Gerrish, and Chief Scientific Officer Dr. Mehmet Kosoglu, who previously worked for the U.S. Food and Drug Administration. 

According to its Co-Founders, the inspiration to create StimuSIL was multi-faceted. For Ana, part of the inspiration to create the company was a change she noticed around her – especially stemming from the pandemic and its aftermath. Pablo acknowledges his onset of hair loss, while not being keen to experience the side effects of finasteride or other oral DHT blockers, as personal motivation to create StimuSIL.