AC5(TM) Topical Gel FDA Regulation Number 878.4022
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Posted On: 10/20/2017 10:48:33 AM
AC5(TM) Topical Gel FDA Regulation Number 878.40227
Arch Therapeutics moving forward...
"The Company is also working to scale up production and at the present time expects to have commercial product available in the second half of 2018. In the interim, Arch will continue to evaluate its commercialization options and it will provide further guidance as appropriate."
http://ir.archtherapeutics.com/press-releases...to-the-u-s
2017 milestones
Announce grant for self-assembling peptidomimetics patent - completed
Raise capital Done
Submit 510(k) filing for external use to US FDA Completed and accepted as exempt. Ready for marketing.
Remaining...
Ø Establish commercialization strategy
Ø Submit IDE presubmission for internal surgical clinical trial
Ø File CE Mark for EU
Ø Expand IP portfolio / file additional patent application
Arch Therapeutics Reports Favorable Results in Repeat Dose Testing of AC5™ for Subchronic Systemic Toxicity
AC5 was comparable to control when dosed 16 times over two months
FRAMINGHAM, Mass., Sept. 12, 2017 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB:ARTH) (“Arch” or the “Company”), developer of novel liquid, gel and solid hemostatic and wound care devices reported that AC5™ Topical Gel (AC5™) was found to be biocompatible in testing designed to investigate subchronic systemic toxicity. The subchronic systemic testing, which involved repeat, frequent dosing over 8 weeks, is one of a panel of biocompatibility evaluation endpoints recommended by US FDA regulatory guidelines for devices such as AC5 to allow use in humans.
http://ir.archtherapeutics.com/press-releases...epeat-dose
September presentation...
https://content.equisolve.net/archtherapeutic...460ea0.pdf
Entering a growing market expected to be $20B by the year 2020.
Hemostatic Agent: AC5™ for control over surgical bleeding.
The AC5 Surgical Hemostatic Device™ - more than just a better mousetrap
The hemostasis market is clearly in search of products that work better, faster, and more reliably. The AC5 Surgical Hemostatic Device™ is designed to do that. Arch believes its products will be significantly superior to what is currently available.
AC5™ is a synthetic peptide comprising naturally occurring amino acids. Evidence to-date supports that it is biocompatible. When squirted or sprayed onto a wound, AC5™ promptly intercalates into the nooks and crannies of the connective tissue where it builds itself into a physical, mechanical structure. That structure provides a barrier to leaking substances, including blood and other bodily fluids, regardless of type of surgery or, based on early data, clotting ability. Healing occurs normally.
The structural building process is called self-assembly, and it provides a new and improved approach to addressing “stasis and barrier applications.”
http://www.archtherapeutics.com/product/product
SEC Filings
https://www.sec.gov/cgi-bin/browse-edgar?acti...p;count=40
Institutional holdings:
http://www.nasdaq.com/symbol/arth/institutional-holdings
AC5(TM) Topical Gel
Establishment Registration & Device Listing
Proprietary Name: AC5
Classification Name: DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC
Product Code: NAE6
Device Class: 1
Regulation Number: 878.40227
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: ARCH THERAPEUTICS8
Registered Establishment Number: 3013521734
Owner/Operator: Arch Therapeutics9
Owner/Operator Number: 10054518
Establishment Operations: Specification Developer
Establishment
NameSort by Establishment Name [A-Z]7
Sort by Establishment Name [Z-A]8 Registration Number Current
Registration Yr
ARCH THERAPEUTICS9 MA/USA
3013521734 2017
dressing,wound,hydrogel w/out drug and/or biologic - AC5 10
Specification Developer
https://www.accessdata.fda.gov/scripts/cdrh/c...p;lpcd=NAE
Edited: Product Classification:
Device dressing,wound,hydrogel w/out drug and/or biologic
Regulation Description Hydrogel wound dressing and burn dressing.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product Code NAE
Premarket Review Office of Device Evaluation 6(ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type 510(K) Exempt
Regulation Number 878.40227
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report8
GMP Exempt? No
Note: FDA has exempted almost all class I devices (with the exception of reserved devices9) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-89210. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-89211, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website12 for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
https://www.accessdata.fda.gov/scripts/cdrh/c...fm?ID=5643
Arch Therapeutics moving forward...
"The Company is also working to scale up production and at the present time expects to have commercial product available in the second half of 2018. In the interim, Arch will continue to evaluate its commercialization options and it will provide further guidance as appropriate."
http://ir.archtherapeutics.com/press-releases...to-the-u-s
2017 milestones
Announce grant for self-assembling peptidomimetics patent - completed
Raise capital Done
Submit 510(k) filing for external use to US FDA Completed and accepted as exempt. Ready for marketing.
Remaining...
Ø Establish commercialization strategy
Ø Submit IDE presubmission for internal surgical clinical trial
Ø File CE Mark for EU
Ø Expand IP portfolio / file additional patent application
Arch Therapeutics Reports Favorable Results in Repeat Dose Testing of AC5™ for Subchronic Systemic Toxicity
AC5 was comparable to control when dosed 16 times over two months
FRAMINGHAM, Mass., Sept. 12, 2017 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB:ARTH) (“Arch” or the “Company”), developer of novel liquid, gel and solid hemostatic and wound care devices reported that AC5™ Topical Gel (AC5™) was found to be biocompatible in testing designed to investigate subchronic systemic toxicity. The subchronic systemic testing, which involved repeat, frequent dosing over 8 weeks, is one of a panel of biocompatibility evaluation endpoints recommended by US FDA regulatory guidelines for devices such as AC5 to allow use in humans.
http://ir.archtherapeutics.com/press-releases...epeat-dose
September presentation...
https://content.equisolve.net/archtherapeutic...460ea0.pdf
Entering a growing market expected to be $20B by the year 2020.
Hemostatic Agent: AC5™ for control over surgical bleeding.
The AC5 Surgical Hemostatic Device™ - more than just a better mousetrap
The hemostasis market is clearly in search of products that work better, faster, and more reliably. The AC5 Surgical Hemostatic Device™ is designed to do that. Arch believes its products will be significantly superior to what is currently available.
AC5™ is a synthetic peptide comprising naturally occurring amino acids. Evidence to-date supports that it is biocompatible. When squirted or sprayed onto a wound, AC5™ promptly intercalates into the nooks and crannies of the connective tissue where it builds itself into a physical, mechanical structure. That structure provides a barrier to leaking substances, including blood and other bodily fluids, regardless of type of surgery or, based on early data, clotting ability. Healing occurs normally.
The structural building process is called self-assembly, and it provides a new and improved approach to addressing “stasis and barrier applications.”
http://www.archtherapeutics.com/product/product
SEC Filings
https://www.sec.gov/cgi-bin/browse-edgar?acti...p;count=40
Institutional holdings:
http://www.nasdaq.com/symbol/arth/institutional-holdings
AC5(TM) Topical Gel
Establishment Registration & Device Listing
Proprietary Name: AC5
Classification Name: DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC
Product Code: NAE6
Device Class: 1
Regulation Number: 878.40227
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: ARCH THERAPEUTICS8
Registered Establishment Number: 3013521734
Owner/Operator: Arch Therapeutics9
Owner/Operator Number: 10054518
Establishment Operations: Specification Developer
Establishment
NameSort by Establishment Name [A-Z]7
Sort by Establishment Name [Z-A]8 Registration Number Current
Registration Yr
ARCH THERAPEUTICS9 MA/USA
3013521734 2017
dressing,wound,hydrogel w/out drug and/or biologic - AC5 10
Specification Developer
https://www.accessdata.fda.gov/scripts/cdrh/c...p;lpcd=NAE
Edited: Product Classification:
Device dressing,wound,hydrogel w/out drug and/or biologic
Regulation Description Hydrogel wound dressing and burn dressing.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product Code NAE
Premarket Review Office of Device Evaluation 6(ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type 510(K) Exempt
Regulation Number 878.40227
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report8
GMP Exempt? No
Note: FDA has exempted almost all class I devices (with the exception of reserved devices9) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-89210. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-89211, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website12 for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
https://www.accessdata.fda.gov/scripts/cdrh/c...fm?ID=5643
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2017 Planned Milestones
v Announce grant for self-assembling peptidomimetics patent
v Raise Capital
Submit 510(k) filing for external use to US FDA ~mid-year 2017
File CE Mark for EU commercialization
File IDE for internal surgical clinical trial (for planned PMA application)
File additional patent application(s)
Establish commercialization strategy
Provide data from multiple preclinical programs in pipeline
As of May 1, 2017, 150,769,042 shares of the registrant’s common stock were outstanding.
10-Q https://www.sec.gov/Archives/edgar/data/15375...43_10q.htm
Clinical-Regulatory Plan for AC5
Adding 510(k) to US regulatory strategy
Medical device pathway
EU and US Regulatory interactions begun
Device met primary and secondary endpoints of EU clinical (human) trial
46 pts. with 10 on antiplatelet therapy (blood thinner)
Safety outcomes comparable between AC5 and control; no serious adverse effects
41% improvement in median time to hemostasis (TTH) versus control
TTH ≤30 seconds in groups of AC treated wounds (+/- antiplatelet therapy)
Regulatory filings
US
510(k) for external topical use
Advanced filing plans to mid-2017
Internal resources focused
Benefits include business opportunities, technology validation
PMA for internal use
File IDE for surgical trial in 2017
EU
CE Mark – file application as soon as possible in 2017
Potential use of US surgical data for internal use application
content.equisolve.net/archtherapeutics/media/c6dc3c52a4e0458fae43779086460ea0.pdf
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