Bellus Medical Continues Global Expansion with Australian Approval

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Flagship product, SkinPen® Precision, is the first and only medical grade microneedling device approved in Australia.

SkinPen Precision is the ONLY Microneedling Device Approved in Australia

Our commitment to safety and quality has resulted in a year of significant accomplishments for Bellus Medical.

Bellus Medical, a leader in medical aesthetics products and devices, is pleased to offer the skin-enhancing benefits of the industry-leading SkinPen® Precision in Australia. SkinPen® Precision is Bellus Medical’s flagship product, and now with approval from the Therapeutic Goods Administration (TGA), Bellus will partner with Advanced Skin Technology to distribute SkinPen® Precision to practitioners in Australia.

TGA, the agency that regulates medical devices and pharmaceuticals in Australia, has approved the SkinPen® Precision microneedling system as a Class II medical device utilizing Collagen Induction Therapy (CIT) to treat Melasma, acne scars, and surgical scars. For a device to be registered in the Australian Register of Therapeutic Goods (ARTG), there is an approval process that must be followed. Manufacturers must ensure their products comply with the essential principles of safety and performance, including clinical performance, and must document a comprehensive risk assessment for every product.

“We are thrilled for SkinPen® Precision to be the only TGA approved microneedling system in Australia,” said Joe Proctor, Bellus Medical President and CEO. “Our commitment to safety and quality has resulted in a year of significant accomplishments for Bellus Medical. TGA approval follows the Medical Device License we received from Health Canada, the CE Mark registration for Europe, along with the ISO 13485:2016 certification. This further positions us as an industry leader and trusted provider within aesthetic medical devices.”

About SkinPen® Precision
The SkinPen® Precision microneedling system raises the standard in technology and is backed by the highest medical device standards available to practices and their patients. The SkinPen® Precision microneedling system is the only device on the market exclusively designed and engineered with the following safety features:

  • Proprietary: Patent pending sterile, single use microneedle cartridge which houses a reciprocating mechanism typically enclosed in the microneedling pen, ensuring a long-term reliability of the SkinPen® Precision device.
  • Safety: Ingress protection to prevent any blood, fluid or serum present during the procedure from penetrating into the pen.
  • Precision: 14 stainless steel medical grade needles create 98,000 micro-injuries per minute for increased efficiency.
  • Protection: Bio-Sheath designed specifically for SkinPen® Precision helps protect patients from potential cross-contamination, ensuring the fluids generated during the procedure do not pass from contaminated glove to SkinPen® Precision device.
  • Clinical: Clinically proven safe, effective and minimally-invasive with little downtime.

The SkinPen® system is now available for purchase by medical practitioners in Australia. To learn more about the revolutionary SkinPen® from Bellus Medical, watch this video. For more information and to place an order, contact Bellus Medical at 888.372.3982 or info@bellusmedical.com.

About Bellus Medical

Bellus Medical, headquartered in Addison, Texas, is an industry leader in medical aesthetics with an unmatched reputation of providing the highest levels of safe and effective products, along with the most innovative technology on the market. Bellus Medical was founded in 2012 and quickly became a pioneer in the medical microneedling industry with the introduction of its flagship product SkinPen® Precision, a state-of-the-art microneedling device. The product portfolio continues to expand with unique and differentiated products to enhance the patient experience and represent a significant business opportunity for medical practices. Bellus Medical is the first, and currently the only, microneedling company in the medical aesthetics industry to earn the prestigious ISO 13485:2016 Certification. Built upon three guiding principles – technology, education and customer service – Bellus is much more than a supplier to aesthetic practices, it is a trusted business partner. To learn more about Bellus Medical, visit http://www.BellusMedical.com. To learn more about SkinPen® Precision microneedling system, visit http://www.SkinPen.com

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Jelena Boldt
@BellusMedical
since: 09/2013
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