In the few months since SkinPen® by Bellus Medical became the first and only US FDA-cleared microneedling device, part of the aesthetic medical industry’s ‘wild west’ is finally coming under control

IN THE DALLAS, TX, SUBURB OF ADDISON, under the flight paths of corporate jets arriving and departing from the nearby executive airport, along a street lined by nondescript light industrial buildings sits the world headquarters of Bellus Medical.

Open one of the glass double doors and walk through the compact, modernistic lobby, down a corridor hung with flags from several countries, then hook a left at the T‑intersection. Along the opposite wall, displayed in a simple diamond pattern, hang 14 framed documents: Bellus Medical’s domestic and international certifications.

Bisecting the ISO certification ‘by Royal Charter’ on the left and the medical device licenses from Canada, New Zealand, and Australia on the right hang four pages of a document from the US Food and Drug Administration (FDA) dated March 1, 2018, which read, ‘FDA concludes this device should be classified Class II.’

Figure 1 Comparison between SkinPen® needle and unapproved needles on the market

*Independent research technology company evaluated major brands in the derma microneedling market. Supporting macro and micro photographs of each needle and cartridge were generated, and each derma microneedle brand examined. Data on file.

**Evaluated by independent laboratory. Data on file.

Sometimes big revolutions come from small companies.

With the stroke of a pen, and after 3 years of proactive work designed to clean up the microneedling space, the FDA established a new microneedling category and set its classification as the Rx-only Class II. Bellus’ flagship product, SkinPen®, is the only legally marketed microneedling device with the correct classification.*

The intended use? Improve the appearance of facial acne scars of people 22 years and older. Moreover, the FDA clearance covers the entire protocol: the SkinPen device, the sealed Precision Advanced Cartridge Unit, the Skinfuse® Lift HG hydrogel used to protect against abrasion and friction during the treatment, and a custom-designed sheath to prevent cross contamination.

As a result of the clearance, Bellus is currently taking a record-setting number of orders for SkinPen.


The mechanical process of using tiny needles to create thousands of ‘micro’ channels in the skin to stimulate the natural healing and remodeling process required a thorough cleanup. Though it’s been safely used by dermatologists, plastic surgeons, and aesthetic physicians for a wide variety of skin conditions since the 1990s, the treatment suffered from little oversight, no definite regulation, and frequent abuse.

That’s all changing, thanks to the advent of the FDA-cleared SkinPen. A recent independent study found a marked difference in quality between needles in adulterated devices and the No. 1 ranked SkinPen. Other suppliers’ needles were often non-sterile, jagged, and even hooked, while the needles in SkinPen cartridges were sterile and straight (see Figure 1).

‘It’s way past time to get the “wild west” of microneedling under control,’ said Bellus Medical President and CEO Joe Proctor. ‘Leading aesthetic healthcare providers agree with us that protecting your patients and growing your business not only can but must go together.’

For Mr Proctor, a 15-year veteran in medical aesthetics, that meant launching a company in 2012 dedicated to helping physician-directed practices succeed by attracting new customers to the industry through minimally invasive technologies and by setting the standard for safety.

The FDA-cleared protocol

Technically, the ‘SkinPen Precision System’, comprised of SkinPen and the SkinPen + Skinfuse® treatment kit,  is to date the only microneedling system approved for use in Canada, Australia, New Zealand, and the EU for the intended use of treating melasma, acne scars, and surgical scars.Proctor credits this international — and now domestic — recognition to Bellus’ unique business focus.

‘While we’re a small company,’ said Mr Proctor, ‘with the principles of practice success and patient protection at our foundation, we are much more than just another supplier. We see our team as their business partners, and we teach our customers how to move from satisfied patients to loyal practice advocates. Helping practices stay on top through technology and safety is what’s truly revolutionary.’

The latest advancement in microneedling

Microneedling is on the rise. It’s a growing part of the 2.5 million annual US and global skin rejuvenation and renewal procedures that include such alternatives as chemical peels, injectables, and laser skin resurfacing.§

SkinPen aims to capitalize on the increasing interest by putting safety first through several product firsts:

  • First medical-grade microneedling product in the US market with precise and safe needle-depth adjustment
  • First validated sterile cartridge with straight needles to support the skin’s natural healing process
  • First laboratory-tested, proprietary technology to prevent cross-contamination.

But how does it all work? Thomas Hitchcock, Ph.D., and Bellus chief medical science officer, explained: ‘SkinPen stimulates your skin’s natural ability to repair itself by creating thousands of precise micro-injuries in the dermis, triggering tissue remodeling without causing scar tissue formation.’

SkinPen gets those results through advances in precision. Its variable depth settings and cordless design provide significant versatility. As a result, physicians can adjust the treatment as appropriate for different areas of the face, as skin thickness can differ from area to area, and to fit the individual needs on each patient’s skin.

Expert practitioners claim the device simply works. ‘When we’re bringing a new service into our practice, we look for a couple of things,’ said Dr Jeff Angobaldo, a plastic surgeon and owner of Renaissance Med Spa in Plano, TX. ‘The most important is how safe it is — if it’s FDA-cleared for the service we’re providing. The second thing is if it’s effective. I’m not going to buy a machine or a product that doesn’t work. SkinPen is fantastic because it works and is very safe.’

SkinPen patients concur, as 90% of subjects in a clinical trial said they would recommend the treatment to friends and family.¦ For results with actual patients, see before and after photos at Figures 2–3.

The procedure typically takes about 20 to 30 minutes, depending on the size and number of areas treated. As a bonus, microneedling patients can return to regular activity relatively quickly. ‘SkinPen is the only FDA-cleared microneedling pen used for facial acne scarring,’ said Dr Angobaldo of Renaissance Med Spa. ‘Bellus Medical shares my passion for excellence by providing the safest and most effective treatment for my patients.’

SkinPen also reduces the risk of cross contamination. An enhanced exhaust port prevents suction and reduces the amount of potential contaminants that can get into the cartridge. Additionally, a single-use disposable ‘BioSheath’ is employed to prevent contamination of the SkinPen device during the treatment.

More fundamentally, SkinPen qualifies as ‘biocompatible’ because none of its components pose an unacceptable risk of a potential adverse biological response. Similarly, the device is compliant with the Restriction of Hazardous Substances (RoHS), a European Union rule that restricts the use of hazardous materials in electrical and electronic products.

The business side of microneedling

Practice owners see the value of microneedling in general and SkinPen in particular.

Figure 2 Female patient before (A) and after 6 procedures (B). Courtesy of Cathy A. Presnick, Licensed Aesthetician. A Perfect Complexion, LLC. Melbourne, FL.

‘Microneedling has become a staple in medical practices and for good reason,’ said Terri A. Wojak, President of True U Esthetics in Chicago, IL. ‘It is a safe and effective way to trigger a wound response in the skin to stimulate the growth of new healthy proteins.’

Priced affordably, especially when compared to other large capital equipment purchases, microneedling can be a profitable treatment to offer for aesthetic practitioners. It integrates well into plastic surgery and facial plastic surgery practices, dermatology offices, as well as medical spas. It can also be safely delegated to physician extenders and aestheticians, depending on applicable regulations.

‘SkinPen is easy to use, and a treatment may be performed in under 20 minutes with minimal discomfort to the patient,’ added Ms Wojak of True U Esthetics. ‘Since we have brought SkinPen into the practice, we have increased the number of microneedling treatments performed and have seen great patient satisfaction.’

Aside from the revenue generated by a new FDA-cleared aesthetic category, practice owners have another reason to consider SkinPen: regulatory compliance that will limit competition from spas and other non-Rx aesthetic rivals.

‘Bellus Medical is proud to stand behind the first compliant microneedling device cleared by the FDA,’ said Bellus medical director of quality and regulatory Jennifer Block. ‘Our focus was to provide the aesthetic industry with a revolutionary device that deserved a class of its own, and SkinPen did just that. It’s is the only legal microneedling device on the market.’

Though there’s no way to know what the FDA might do to sellers or users of adulterated devices, Block said the compliant path is the best path, for both practices and patients: ‘By choosing products from Bellus, you can ensure you’re partnering with a company that takes compliance seriously. Our products are tested, validated, and compliant to ensure patients receive a high-quality experience. At best, other mechanical devices have unknown effects and at worst, they can harm patients. Using SkinPen gives practice owners and users much-needed peace of mind.’

Figure 3 26-year old male patient before (A) and after 3 procedures (B). Courtesy of Elizabeth Steigner, Medical Aesthetician. Turpin, MD Plastic Surgery & Medical Aesthetics, Orange, CA.

In a sense, delivering peace of mind for aesthetic healthcare providers drives Bellus’ entire product line: SkinPen, the post-microneedling protocol Skinfuse, the light-activated cream Allumera®, and the platelet-rich plasma systems ProGen™ and RegenLab®.

‘We limit our focus to physician practices, which means we fully invest in growing their business and fending off competition from spas or cosmetics,’ Bellus CEO Proctor said. ‘Our products produce impressive results by keeping patients’ skin looking healthy and youthful for the long term. Bellus’ combination of effective and Rx-only products demonstrates our unique commitment to putting our customers’ interests first.’

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