Arch Therapeutics Inc (ARTH)

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"Dr. Norchi says the company is working on a next generation kit that would contain prefilled syringes, compared with the current AC5 powder that must be mixed.

Arch’s plan is to file for CE Mark approval as soon as possible this year. A 510(k) filing for topical use of AC5 in the U.S. has been advanced to mid-2017 from the earlier plan of late-2017.

The company also expects to file an investigational device exemption with the FDA this year for an AC5 surgical trial in order to obtain premarket approval (PMA) of the device for internal use.

"Our anticipated 510(k) filing focusing on external skin applications should present a nearer-term opportunity for AC5, compared with our previous plan of filing a PMA for all uses in the U.S.,” Dr. Norchi says.

“We anticipate that the potential benefit from an earlier 510(k) filing is significant in terms of business opportunity and technology validation,” he adds. “Our intent to file a PMA for internal use after completing the necessary human clinical work also remains intact."

https://www.biotuesdays.com/features/2017/3/2/arch-moving-to-regulatory-stage-this-year


"“We believe those firms will be increasingly attracted to, if not threatened by, Arch’s AC5 hemostat as it continues to develop,” Roth Capital Partners analyst, Michael Higgins, wrote in an initiation report last month. He believes that AC5 has the potential to “revolutionize the hemostat market.”

Mr. Higgins rates Arch shares at “buy” with a 12-month price target of $3. The stock closed at $0.63 on Friday. "