StimuSIL’s SAGA-001: A New Paradigm in Laser Therapy for Hair Loss
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.
StimuSIL’s Goals and Upcoming Webinar
If you’re like me and interested to learn more about StimuSIL and the SAGA-001 device, Pablo Villalba and CMO Dr. Scott Gerrish will be hosting a webinar. They’ll share exclusive data and explain everything about their medical device, fundraising efforts, market strategy, and new clinical trial in detail. There will also be time to ask them any questions you may have. After first reviewing StimuSIL’s technical efforts into innovation, learning of their interests in other potential pipeline therapies for hair growth beyond this device, and acknowledging a previous investment StimuSIL received from a European pharmaceutical company, Follicle Thought has created an affiliation with StimuSIL to share this information and webinar with you all. Sign-up information is listed below. Note, this is not financial advice.
Update: The webinar has been postponed.
Everyone who signed up for StimuSIL’s webinar, like myself, was contacted and informed that the webinar was postponed due to StimuSIL’s CMO Dr. Gerrish encountering a last minute flight delay. The current date for rescheduling is Thursday, July 13th, at 1 PM EST.
Register here ✍: Webinar Sign Up Form
Please share this post with all who would be interested in learning more about StimuSIL’s interesting new device.
Posted in Hair Growth Treatment, Laser Hair Therapy, StimuSIL
As several readers have requested it, we’ve decided to try opening the comments again. At the start, all comments will go through moderation to relieve the need for constant monitoring. We’d like this to be a fun place where readers can connect and share ideas. Please help the comments to stay open by keeping the discussion mature and polite. Looking forward to hearing from the long time supporters. Note, I’m traveling at the moment and won’t be able to respond to questions initially. Thanks for your patience.
To share a few thoughts, I find it encouraging that StimuSIL will go through a clinical trial before the device potentially becomes available in clinics. I own an old school laser comb which sits in my drawer nowadays, and I’ve never been too big on traditional LLLT. However, I see a meaningful potential in the new dimension that StimuSIL has added with their device and I’m going to follow their progress over the next several months. Above all, I’m looking forward to see what the initial trial data will show. You are able to ask questions for StimuSIL here, as members of the company will respond to the questions that they can at this time.
Hi, just a thought if this device crosses the melanin layer does that mean there’s a chance that it could regenerate the melanocytes and darken hair too? As ive heard of some LLLT devices darkening hair sometimes. Interesting company and look forward to hearing more about this.
Hi Andy, Siddhi from StimuSIL here. I’m a postdoctoral researcher and also manage our comms.
You’re right – we also noticed that photobiomodulation sometimes darkens hair! Most studies we found reported it as an occasional side effect rather than a consistent result. I’m curious about what you’ve found. Could you point me in the direction of what you’ve seen on LLLT devices darkening hair?
We’re currently only running clinical trials for hair loss. However, we’re also exploring ways to regulate melanogenesis. We’ll share a little more about our research on this during our webinar. We’ll also be taking questions – so feel free to join us and ask anything else you’d like to find out.
Hey Admin, great to have the comment section back! 🙂 Thanks for that!
I think the StimuSil concept is great and has potential. Its safe and can be on the market in short time. We have to wait what results it brings. I really hope they release statistic results and before / after pics with same light and angle and same hair cut.
I am still bit sceptical as we have seen so many claims and then the results are like 2 hairs more after 6 months. And with the given downsides this Stimusil model has the results should be stunning! Downsides are the in office use. I mean its not only the half hour treatment. You maybe have to drive an hour to get there. Also many patients (especially woman) wear hair pieces which they must remove first. So it means at least the half day is gone just for that.
So the results should be huge to accept the trouble.
Question: What are the results and will there be a home use device? (I would prefer home use)
Hi John, Siddhi from StimuSIL here. I’m a postdoctoral researcher and also manage our comms.
We hope to share statistical results, before and after pictures, and detailed trichoscopy pictures (courtesy of TrichoLab) by the end of the year. We also plan to share case study photos during our webinar if you want to see results sooner!
Also, I hear you concerning the time commitment an in-office treatment involves. We’re aiming for people based in cities to receive their treatments in as little as 20 minutes. The good news is that you only need to go in once every two weeks for the first few months. You can then get maintenance treatments less frequently (as needed).
We hope women find our treatments particularly appealing since they can easily book them alongside other aesthetic treatments. Plus, they won’t need to cut their hair (like they would for FUE). We’re also working on complementary home-use treatments that will enhance results even further.
If you’d like to find out more, join our webinar! Our CMO, Dr. Scott Gerrish, and Co-Founder Pablo Villalba will be answering everyone’s questions personally.
Hi Siddhi, many thanks for your answers. Really appreciate it!
When can we expect its release and in what way is it different than ManeBiotch solution.
Thank you
Hi Ahmed, Siddhi from StimuSIL here. I’m a postdoctoral researcher and also manage our comms.
Mane Biotech has created a home-use device based on electrical stimulation. StimuSIL’s device is for clinical practitioners to apply to patients and uses a new form of photobiomodulation (laser hair therapy). Mane Biotech is essentially stimulating hair follicles using electricity, while StimuSIL’s SAGA-001 stimulates hair follicles using a combination of laser light and mechanical stimulation. We decided to create a device for clinical use because devices used in clinics can use more intense laser stimulation parameters compared to home devices.
I hope that answers your question! If you’d like to find out more, come to our webinar!
Missed commenting on the page feels good again lol
Glad to have you back, YoYo.
Nice piece FT (although I didn’t receive an email alert for the post for some reason). You don’t appear to mention that the device/procedure is targeted for US and EU release next year?
Hi LJ, Siddhi from StimuSIL here. I’m a postdoctoral researcher and also manage our comms.
We’re currently running clinical trials and are indeed targeting our release for 2025. We’ll share more information about our timelines during our webinar if you’d like to learn more.
LJ, yes for some reason WordPress did not send an email alert unexpectedly this time. I will be sending a follow up reminder post soon so that everyone gets the alert about the post.
Hi Dr. Siddhi Camila Lama,
In which stage of hair loss is your device effective, between Norwood 2-7?
Hi iL44!
Our current clinical trial is currently exploring Norwood Hamilton 2a through 5, but we are simultaneously exploring stages 5-7 in case studies and have had promising results. We intend to expand the indication to stages 2-7 in the near future. We think our treatment will work particularly well for people with advanced androgenetic alopecia since they’ll also be able to combine multiple therapies under professional supervision to enhance their results.
Thanks for the reply, by exploring ways of regulating melagenosis does this mean possible hair repigmentation route? As I see a research area on the pipeline page for vitiligo as a skin pigment issue. As for the LLLT hair darkening I have just read about or seen a few before and after pictures of users saying there hair colour had darkened while using, sounds like a nice side effect lol. But unfortunately the LLLT helmets I’ve seen are very pricey and not overall proven to regrow much hair.
Hi again, Andy!
Yes, we are actively exploring hair repigmentation. Vitiligo is within our exploratory pipeline, too.
That’s pretty interesting regarding the LLLT users you’ve mentioned. Do you recall if their devices had LEDs or lasers? Did they always use red light?
So far, our understanding of current LLLT devices is that they’re severely underpowered for hair loss since the melanin layer stops most of the light, blocking the potential therapeutic benefit. That’s why we’re pushing forward with new technology that can reach the full potential of laser therapy.
FT4president