FDA accepts label update for Suneva’s handheld plasma energy device

Suneva Medical announced today that the FDA accepted updates to its Plasma IQ handheld plasma energy device.

San Diego-based Suneva designed the Plasma IQ for the removal and destruction of skin lesions and coagulation of tissue. The company touts Plasma IQ as the first handheld, FDA-cleared plasma energy device with such indications.

According to a news release, the updated label includes the removal of the product’s eye contraindication, due in part to literature provided to the FDA that showed the safety and efficacy of the ablative device on skin tissue, particularly around the eye area. The new label update allows Suneva to address treatment around the eye for patients in the U.S.

Plasma IQ delivers focused, controlled energy to create micro-injuries on skin, renewing and restoring it. The platform is prescription only, owned and manufactured by Neauvia with Suneva responsible for North American distribution.

Suneva earlier this month e…

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Suneva Medical raises $25.1m

Regenerative aesthetic product developer Suneva Medical filed an SEC Form D last week that confirmed the sale of nearly $25.1 million in equity.

The San Diego-based company met its total offering amount of $25.098 million after making the first sale for the new notice on May 15. It did not intend for the offering to last for more than a year, and it ended up lasting for less than one week.

In total, five investors contributed to the offering, which Suneva Medical confirmed in the filing is not being made in connection with a business combination transaction, including a merger, acquisition or exchange offer.

Suneva Medical did not list an intended use of proceeds, but its current portfolio includes four main products, according to the company website.

The company develops Bellafill for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek. It also produces the Puregraft product that has CE …

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