Category Archives: LLLT

LLLT, Microneedling, StimuSIL

StimuSIL SAGA-001 Precision LLLT

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In my last post on pulsed electromagnetic field therapy (PEMF), I mentioned a recent August 2024 paper funded by StimuSIL (US). In there, the authors describe in detail a new hair growth technology and device from StimuSIL that combines laser and microneedling. It is supposed to be significantly superior to traditional low-level laser therapy for hair growth.

StimuSIL SAGA-001: Combined Laser and Microneedling

The new StimuSIL (US) hair growth device is called SAGA-001 and is only meant for in-clinic use. Most hair loss treatments entail daily usage (e.g., pill, topicals or laser caps/helmets/combs). In contrast, SAGA-001 treatments are only required once every two weeks. StimuSIL was co-founded by CEO Ana Villalba and Chairman Pablo Villalba.

StimuSIL’s initial SAGA-001 clinical trial was just completed in Turkey on September 1, 2024. The purpose of the 24-week study was to see if the SAGA-001 device is safe and effective at treating male pattern hair loss.

The original 2023 trial commencement announcement calls the product a “novel microneedling and laser device for male pattern hair loss”. The SAGA-001 device combines microneedling and laser light delivery for hair growth. The manufacturer calls this patented technology “precision low-level laser therapy (LLLT)”. StimuSIL does not have much on its website regarding the exact nature of this subdermal laser process.

StimuSIL SAGA-001
StimuSIL SAGA-001 precision LLLT. Combining laser energy and microneedling for hair growth.

The device uses lasers that are first inserted into the skin’s dermis in order to avoid loss at the melanin level. According to the new paper’s authors:

“Precision LLLT utilizes a novel approach to photobiomodulation delivery, which is intended to reproduce the success of combining minoxidil with microneedling.”

The SAGA device pierces through the skin’s epidermis layer using novel optical microneedles. These needles bypass the melanin layer in order to safely and efficiently deliver more energy to the hair follicles.

On StimuSIL’s website, they state that when conventional laser hair growth devices shine light over the epidermis, most of it is blocked due to the melanin layer. Per the image above from their study, a staggering 80% of the low-level laser’s light energy is blocked by the skin’s melanin. And another 5% is reflected of the surface. So only 15% gets down to the dermis layer from where the hair follicles arise. Quite hard to believe.

The company’s proprietary technology:

“Aims to deliver PBM across the melanin layer of the skin in order to enhance this treatment’s biostimulatory effects.”

StimuField

Also significant, On August 2, 2024 StimuSIL announced plans to launch StimuField, a new wearable product entering their biomedical device pipeline. StimuField uses pulsed electromagnetic field therapy to improve hair and scalp health in men and women. I discussed this development in my earlier mentioned PEMF and hair growth post.

Below is a comparison image of the various treatments from the StimuSIL’s new paper:

StimuSil Precision LLLT
StimuSIL Precision LLLT. Source: Journal of Clinical Medicine, August 2024.
iRestore Laser, LLLT, Low Level Laser Therapy

iRestore Elite Device for Hair Growth

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iRestore Elite Laser
New iRestore Elite laser device for hair growth.

In my post on the best laser hair growth devices, one of the products I covered was the iRestore laser helmet from Freedom Laser Therapy. Until 2023, the company made two devices that they call laser hair growth systems. Sometimes they also use the terms “laser cap” and “laser helmet”.

  • The iRestore Essential with 120 lasers and LEDs (light-emitting diodes). Current average rating of 3.9 out of 5 stars across 3,800 reviews on Amazon. On sale for $500 after $100 coupon.
  • The iRestore Professional with 282 diodes (both laser and LED). Current average rating of 4.2 out of 5 stars across 940 reviews on Amazon. On sale for $800.

iRestore Elite Laser Helmet with 500 Diodes

In 2023, Freedom Laser released the newest iRestore Elite model with a huge 500 combined laser and LED diodes. The white color of prior models has been replaced by a sleep black appearance.

This device is FDA cleared for home use for hair regrowth purposes.

According to the company’s website, the iRestore Elite comes with the following features and advantages

  • 500 diodes (Lasers & LEDs). The most in any home-use laser hair growth device on the market. I have not tried to verify this claim.
  • 2500 mW total power output.
  • Brief daily 12-minute treatment time.
  • Unique triple wavelength red light technology (625/655/680 nm) for deeper scalp stimulation. Make sure to read my post on low-level laser therapy (LLLT) and wavelength.
  • Proprietary Lumitech™ red light therapy.
  • Advanced vertical-cavity surface-emitting lasers (VCSELs).
  • A patented extended scalp coverage for maximum effectiveness. It stimulates hair follicles in the temples, crown and hairline regions of the scalp.

The lasers are medical-grade VCSEL with a wavelength of 680 nm. The LEDs are medical-grade with wavelengths fo 625 nm and 655 nm. Kevin Chen, the president of iRestore, says that the Elite is the most powerful hair growth device for home use. It is sometimes called the “Ferrari of Hair Growth Devices.”

The iRestore Elite device can be purchased for $1,900 after a $600 off discount offer with a promo code. You can also buy a rechargeable battery pack that is on sale at $89. A 3-year warranty is included, and it can be extended to 5 years for an additional fee.

What’s Included

The hands-free helmet (not cap) itself has a ventilated design with adjustable soft foam pads so as to fit every head size perfectly. IT weight only 1.2 lbs.

Included in the purchase price are:

  1. The iRestore Elite device.
  2. A universal power adaptor.
  3. A controller with timer display.
  4. User manual.
  5. Quick start guide.
  6. A protective carrying case.
iRestore Elite Laser Helmet
iRestore Elite Laser Helmet.