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Arch Therapeutics Inc (ARTH) RSS Feed

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Arch Therapeutics, Inc.

Overview

Arch Therapeutics, Inc. (Arch) is a biotechnology company developing an innovative, elegant, and superior approach to the rapid cessation of bleeding (hemostasis*) and control of fluid leakage (sealant) during surgery and trauma care. The underlying technology, exclusively licensed from a leading university, supports an innovative platform of smart materials that fulfill the criteria as a solution for a specialized field we call, “stasis and barrier applications.”

Physicians, industry and patients could benefit greatly from a universal sealant for the challenges presented when an opening is created in the body, whether via surgery, trauma, colonoscopy biopsy, device implantation, or in a variety of consumer settings. The surgeon must manage and preferably prevent bleeding and leakage, as well as other challenges. Currently available tools designed to resolve these problems are often inadequate.

Arch intends to transform the landscape of interventional healthcare with products to seal and protect leaking and bleeding tissue. Arch’s solution elegantly controls the movement of these fluids and substances.

Arch’s products are currently progressing in preclinical development. The first product, AC5 Surgical Hemostatic Device,™ is designed to achieve hemostasis in minimally invasive (laparoscopic**) and open surgical procedures and is intended to be regulated as a medical device.

Surgeons would deem the product a “must have” because of its tremendous features, making it very different and far advanced compared to anything currently on the market.

AC5™ stops bleeding promptly. Unlike many competitive products, it conforms to irregular wound geometry, allows for normal healing, and helps maintain a clear field of vision directly into the wound area.

Because it is not sticky or glue-like, it is ideal for use in the laparoscopic setting – a challenge for much of the competition. Furthermore, it is transparent, enabling a surgeon to operate through it in order to prophylactically stop bleeding as it starts – an important advancement we have branded as Crystal Clear Surgery™.

Most importantly, time to hemostasis (TTH) for AC5™ is typically measured in seconds, rather than the many minutes as provided by much of the competition.

In preclinical tests, the AC5 Surgical Hemostatic Device™ has been simple, effective, and versatile. To date, biocompatibility has been excellent and healing of tissue treated with the device has been normal. This extraordinary concept, if successfully proven clinically, could eventually lead to product adoption available in every surgical setting across the globe.

*Hemostasis or haemostasis (from the Ancient Greek: α?μ?στασις haimóstasis "styptic (drug)") is the process of stopping bleeding, or preventing blood from leaking from damaged blood vessels and tissues. (The opposite of hemostasis is hemorrhage.)

**Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a modern surgical technique in which operations are performed through small incisions (usually 0.5–1.5 cm) as opposed to the larger incisions needed in open surgery. Keyhole surgery makes use of images displayed on TV monitors to magnify the surgical elements.

http://www.archtherapeutics.com/

Company Info

Address:
235 Walnut Street
Suite 6
Framingham, MA 01702 US

Telephone:
855-340-2784

Email:
investors@archtherapeutics.com

Industry Classifications

Sector:
Industrials

Industry:
Conglomerates

NAICS:
Offices of Other Holding Companies (551112)

SIC:
Offices Of Holding Companies, Not Elsewhere Classified (6719)
 

Overview

Arch Therapeutics, Inc.  (Arch) is a medical device company developing an innovative, elegant, and superior approach to the rapid cessation of bleeding (hemostasis*) and control of fluid leakage (sealant) during surgery and trauma care. The underlying technology, exclusively licensed from a leading university, supports an innovative platform of smart materials that fulfill the criteria as a solution for a specialized field we call, “stasis and barrier applications.”

Physicians, industry and patients could benefit greatly from a universal sealant for the challenges presented when an opening is created in the body, whether via surgery, trauma, colonoscopy biopsy, device implantation, or in a variety of consumer settings. The surgeon must manage and preferably prevent bleeding and leakage, as well as other challenges. Currently available tools designed to resolve these problems are often inadequate.

Arch intends to transform the landscape of interventional healthcare with products to seal and protect leaking and bleeding tissue. Arch’s solution elegantly controls the movement of these fluids and substances.

Arch’s products are currently progressing in preclinical development. The first product, AC5 Surgical Hemostatic Device,™ is designed to achieve hemostasis in minimally invasive (laparoscopic**) and open surgical procedures.

Surgeons would deem the product a “must have” because of its tremendous features, making it very different and far advanced compared to anything currently on the market.

AC5™ stops bleeding promptly. Unlike many competitive products, it conforms to irregular wound geometry, allows for normal healing, and helps maintain a clear field of vision directly into the wound area.

Because it is not sticky or glue-like, it is ideal for use in the laparoscopic setting – a challenge for much of the competition. Furthermore, it is transparent, enabling a surgeon to operate through it in order to prophylactically stop bleeding as it starts – an important advancement we have branded as Crystal Clear Surgery™.

Most importantly, time to hemostasis (TTH) for AC5™ is typically measured in seconds, rather than the many minutes as provided by much of the competition.

In preclinical tests, the AC5 Surgical Hemostatic Device™ has been simple, effective, and versatile. To date, biocompatibility has been excellent and healing of tissue treated with the device has been normal. This extraordinary concept, if successfully proven clinically, could eventually lead to product adoption available in every surgical setting across the globe.

*Hemostasis or haemostasis (from the Ancient Greek: α?μ?στασις haimóstasis "styptic (drug)") is the process of stopping bleeding, or preventing blood from leaking from damaged blood vessels and tissues. (The opposite of hemostasis is hemorrhage.)

**Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a modern surgical technique in which operations are performed through small incisions (usually 0.5–1.5 cm) as opposed to the larger incisions needed in open surgery. Keyhole surgery makes use of images displayed on TV monitors to magnify the surgical elements.

Corporate Mission

The Mission of Arch Therapeutics is to develop products that will improve the lives of patients and enhance the quality of care offered by healthcare personnel. We intend to offer compelling options to healthcare institutions facing limited resources.

Arch Therapeutics strives to be a leader in the field of stasis and barrier applications. This includes, but is not limited to, hemostasis and sealant products. We intend to develop products with dramatically improved profiles and characteristics over products on the market or in development. We intend to broaden the scope of the field by developing improved solutions to problems beyond the traditional hemostasis and sealant realms.

Arch Therapeutics is focused on capital efficiency. Our operational plans are geared toward achieving value-creating milestones in a manner that optimizes quality, probability of success, and cost effectiveness.

Arch Therapeutics believes in the value of intellectual property. We intend to file and defend patents and other intellectual property as required, in order to vigorously protect our assets, ideas, and inventions.

Arch Therapeutics plans to achieve its mission with a small core team. The realization of our business objectives amidst the challenges of the modern healthcare environment requires that the best supporting people surround us. We value a healthy mix of seasoned entrepreneurs, scientists, business people and investors in a disciplined environment.

Arch Therapeutics believes that by focusing on the above objectives, we will achieve the goal of providing an optimal return for our investors, to whom we are thankful.

Market Scope

Over 35 million US and 100 million worldwide annual surgeries are driving positive ambulatory and laparoscopic surgical trends

According to MedMarket Diligence, LLC, approximately 114 million surgical and procedure-based wounds occur annually worldwide, including 36 million from surgery in the US, which can benefit from sealants and/or hemostatic* agents.2

These figures are consistent with internal estimates, derived from published data3,4,5 

Trends that support the increasing demand in “biomaterials” include:

  • ambulatory same day surgery volume growth +5% (inpatient volume is -1%)
    laparoscopic procedure volume growth
    operating room time reduction
    - according to MedMarket Diligence, a $115 hemostat that saves four minutes in operating time pays for itself, and these “products can often save anywhere from five minutes to two hours, depending on the procedure.”
    surgeons are expected to meet greater challenges

Target market size and trends

Use of hemostatic agents and sealants is increasing. The market achieved $2B in 2010 worldwide sales and was projected to reach $4B in 20156.  Current projections now indicate sales may exceed $4B in 2013 and $7B in 2017. Over two-thirds of these sales are for hemostats, but a greater sealant growth rate is projected due to a relative paucity of products and an even larger unmet need.

The most useful hemostatic agents can cost upwards of $500/application. Yet a relatively small percent of surgeons use them, often citing their limitations. Supported by views of thought-leaders, improved products would see better uptake, thus growing the already large market.

Another trend is the shift over the past two decades to performing surgery in the less expensive outpatient setting. While this trend continues, bleeding risks force many otherwise straightforward cases to be performed in the hospital inpatient setting, which typically provides greater support for significant potential complications.

The biggest trend is to perform surgery less invasively. Less invasive procedures produce shorter recovery times, faster discharges, less scarring, less pain and less need for pain medications. Open surgery has moved to laparoscopic surgery (25% of procedures). Traditional laparoscopic surgery (three openings) is slowly moving to single-port laparoscopic surgery (one opening), which is more difficult to perform. While still in its infancy, there is a move afoot to advance the techniques of NOTES (natural orifice translumenal endoscopic surgery), which is a method of performing surgery without creating openings in the exterior of the body, by using natural orifices to reach the intended surgical destination instead.

The implication of these trends is that physicians need more advanced materials that are precisely deliverable, easily controlled, maintain a clear field of vision, and work reliably and promptly. Furthermore, the concern of leaking anastomosis in a patient who underwent laparoscopic surgery is prevalent. Some suggest that one of the main hurdles to the uptake of NOTES is concern over leaks after the “opening inside the orifice” is closed.  Many physicians stated they could use our product in the majority of their laparoscopic procedures, especially as prophylaxis against leaks that occur after the patient has moved to a post-operative environment.

Existing Treatments

Arch can transform the landscape. The competition has limitations

“Surveys of general, vascular, thoracic, and neurosurgeons affirm the need for products that will work within one minute (preferably 15-30 seconds), remain effective for 10-14 days, and absorb within 8 weeks…”

Surgical “biomaterials” for hemostasis and sealant are out of date. Surgical (and trauma) patients are at significant risk for morbidity and mortality from bleeding and/or leaking body fluids. While surgical techniques, instrumentation and technology have made tremendous strides over the last couple of decades, the majority of hemostatic agents and sealants that surgeons rely on to help stop bleeding and seal leakages have not kept up. Even though some companies have made incremental improvements on first-generation hemostatic products (example: a recombinant version of thrombin to eliminate adverse effects associated with animal-derived blood products), revolutionary advances have been elusive because the underlying technologies have basic limitations.

Fortunately, thought leaders have been vocal about what is missing, and that is where Arch steps in. Surgeons agree that the ideal agent to stop bleeding or leaking does not currently exist. Surveys of general, vascular, thoracic, and neurosurgeons affirm the need for products that will work within one minute (preferably 15-30 seconds), remain effective for 10-14 days, and absorb within 8 weeks, among other needs. A product exceeding these customer expectations should achieve a high level of success. If it possesses both sealing and hemostasis crossover potential, the opportunity should be further enhanced.

Starting with surgical hemostasis, Arch intends to transform the landscape of interventional care. Whether due to surgery or trauma, burn or biopsy, any hole made in the body must be properly sealed and managed. Customers desire a democratic, multipurpose technology to seal and protect that hole without interfering with normal healing.

While surgeons and trauma care providers have available products to stop bleeding, they are often “me-too” products that are largely variations on relatively narrow and very old themes or classes. These possess significant drawbacks. The underlying technologies confer inherent performance limitations, with implications for the surgeon and the patient.

Drawbacks of these products can include a combination of the following:

  1. Unreliable, slow onset of action
    Does not stop bleeding
    Foreign body reaction, adhesion, granuloma formation, delayed healing
    Infection
    Difficult to prepare and use
    Intact clotting cascade required
    Animal/human sourcing
    Must be kept dry or wet surface causes poor performance
    Removal required
    External application only
    Toxicity potential
    Narrow indications
    Glue-like
     

Competitive Limitations

Category Composition Drawbacks Products
Fibrin/Thrombin,
Collagen/Gelatin
Proteins mostly from
animal or human
  • Unreliable, slow onset of action
    Foreign body reaction, adhesion, infection
    Difficult to prepare and use
    Intact clotting cascade required
    Animal/human sourcing
Tisseel, Evicel,
Evithrom, Thrombin,
SurgiFoam, Floseal,
Avitene, Cellerate
Cellulose/polymer hydrogels Plant cellulose,
Polymer hydrogels
  • Unreliable
    Granuloma
    Poor adhesion and clotting
Surgicel
Others
Desiccants/Concentrators Clay, chitin, starch
powders
  • Must be kept dry
    Removal required
Perclot
QuikClot -Field trauma
Of Peripheral Interest:
Cyanoacrylates Cyanoacrylates
  • Wet surface poor performance
    External application; Toxicity potential
    Does not stop bleeding
Dermabond
Omnex
Neucrylate
PEG Polyethylene Glycol
  • Wet surface poor performance
    Delayed healing
    Narrower indication
Duraseal
Coseal
RTP

Manufacturing

Nanotechnology: design and control at the nanoscale

The mechanism by which the AC5 Surgical Hemostatic Device™ and other Arch planned pipeline products achieves its desired effect resides in the domain of the nanoscale. The design and control of AC5TM provides the desired high ordered nanostructures.


Arch techniques use organic chemistry instead of expensive biotech or plasma-based methods

Simpler manufacturing methods are important

Important determinants of product value are its manufacturing methods, type and source of ingredients, and burden of waste byproduct elimination. Industry is keenly aware of the downside of technologies that rely on expensive biotechnology techniques and facilities for manufacture, onerous and expensive programs to eliminate complex materials, or ingredients that are sourced from the complicated process of human or other animal plasma separation.

Such products typically are expensive, infrastructure intensive, burdensome, and at greater risk for failing regulatory oversight versus simpler options. Arch’s manufacturing methods avoid these complexities.

Arch’s planned products will be synthesized of naturally occurring ingredients that are not sourced from humans or other animals. These ingredients, which are the building blocks of the human body, are categorized as GRAS (Generally Recognized as Safe), convey a lower risk of adverse effects, and exist in their natural state in humans.

Product

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.”

The Need: Modern Surgical Procedures
Drive Demand For Improved Therapies

ac5-PANEL-1.jpgac5-PANEL-2.jpgac5-PANEL-3.jpgac5-PANEL-4.jpgac5-PANEL-5.jpgac5-PANEL-6.jpg
ac5-PANEL-7.jpgac5-PANEL-8.jpgac5-PANEL-9.jpg
 

Every day, around the world, millions of surgical procedures are taking place. Many are planned months in advance, while many more are in response to emergency needs.

Because these procedures are invasive, surgeons and other medical specialists focus on optimizing patient outcomes – and they constantly strive for fewer complications, including reduced fluid and blood loss in order to obtain the best results while maximizing safety and minimizing time to recovery. They also operate today through smaller incisions in the body, in procedures known as minimally invasive or laparoscopic surgery.

The Solution: AC5™ Stasis And Barrier Technology

AC5™ itself is designed at the nano-scale. It's a synthetic peptide comprised of naturally occurring, non-animal, amino acids using straight-forward manufacturing techniques.

AC5™ is applied directly onto a surgical or traumatic wound, where it rapidly creates a physical barrier in the nooks and crannies of the tissue and promptly stops bleeding and fluid leaks.

It's not sticky or glue-like, and is very easy to prepare and handle. It's also a clear transparent gel enabling doctors to see through it as they work, performing “Crystal Clear Surgery™.”

The Result: Faster and Safer Surgical Outcomes

Once applied, AC5™ works quickly to stop bleeding with rapid onset of hemostasis.

With AC5™, surgeons are able to perform surgery through the protective barrier safely.

Once the incision heals, AC5™ is naturally absorbed and passes from the body.

Development

The following charts summarize the dramatic improvement in hemostasis seen to date in animal testing.

chart-avg-time-hemostasis-control-substance.jpg

The chart above shows the improvement of AC5 Surgical Hemostatic Device™ over both a control substance and a control peptide.

chart-avg-time-hemostasis-cautery-saline.jpg

The last chart shows the improvement of AC5 Surgical Hemostatic Device™ over both cautery and saline control substances.

 

chart-avg-time-hemostasis-brain-tissue.jpg

This chart shows how quickly AC5TM stops bleeding in preclinical studies. The barely discernable green bars illustrate the time required for AC5 to achieve hemostasis (bleeding stopped) compared to the control times in red.


Press Releases

10/31/16
http://www.archtherapeutics.com/news/press-releases/detail/483/arch-therapeutics-reports-ac5-topical-hemostatic-device
10/11/16
http://www.archtherapeutics.com/news/press-releases/detail/482/arch-therapeutics-will-present-at-the-2016-bio-investor
 09/12/16
http://www.archtherapeutics.com/news/press-releases/detail/480/arch-therapeutics-provides-corporate-update-at-the-18th
 08/19/16
http://www.archtherapeutics.com/news/press-releases/detail/478/arch-therapeutics-president-and-ceo-terrence-norchi-md
08/15/16
http://www.archtherapeutics.com/news/press-releases/detail/477/arch-therapeutics-reports-ac5-topical-hemostatic-device
06/6/16
Arch Therapeutics Completes Patient Enrollment in Clinical Study of AC5
05/27/16
Arch Therapeutics Announces May 26, 2016 $3.4 Million Private Placement
05/16/16
Arch Therapeutics Announces Issuance of Composition of Matter Patent Covering Self-Assembling Peptidomimetics
05/10/16
Arch Therapeutics Receives Notice of Allowance for Composition of Matter and Method of Use Patent Covering Solid Forms of Self-Assembling Peptides
04/25/16
Arch Therapeutics Receives Notice of Allowance for Patent Covering Systemic Applications for Self-Assembling Peptides
04/11/16
Arch Therapeutics Announces Notice of Allowance for Method of Use Patent Covering Uses of Self-Assembling Peptides
04/5/16
Arch Therapeutics Announces Notice of Allowance for Composition-of-Matter Patent Covering Self-Assembling Peptides
03/22/16
Arch Therapeutics Obtains Favorable Safety Data for AC5 Surgical Hemostatic Device(TM) in Skin Irritation Testing in Humans
03/14/16
Arch Therapeutics Reports Favorable Results for AC5 Surgical Hemostatic Device in Biocompatibility Testing Required for CE Mark
03/9/16
Arch Therapeutics Receives ISO 13485 Certification for AC5
03/7/16
Arch Therapeutics Clinical Trial Actively Enrolling Patients and Providing Investigational Treatment
12/16/15
Arch Therapeutics Receives Clearance to Initiate Clinical Trial in Europe
12/3/15
Arch Therapeutics Receives Notice of Allowance for New Patent