Frequently Asked Questions

What is Ark Sciences doing to promote humane treatment of animals? The executive team at Ark Sciences will not rest until we dramatically reduce the US pet euthanasia rate of 4 million annually. Our vision is Full Adoption USA by 2015. We are now training veterinarians supplying them with our sterilization product. By second quarter in 2012, it will be ready for sale at a price that will allow them to sterilize up to five dogs for the price of one castration (on average), five times faster, and five times safer. We have other products on the way that will be game changing for other animals.

Why is Ark Sciences targeting non-profits? Ark Sciences is a social entrepreneurship venture. It is a mission-based private company founded by Joe Tosini, an ordained minister to honor his commitment to making a difference in the world. He has chosen Ark Sciences and the vast potential of its technology, as the medium to achieve one of his missions: to alleviate the suffering of animals and humans. Substituting one million castrations with Zinc-based sterilizations starting in 2012 will save over $50M of donated dollars every year. Imagine the potential windfall of $50M becoming readily available for other animal welfare programs including dog adoption, responsible breeding, pet education, etc. The Ark Sciences executive team believes this to be an effective way to launch our mission and to educate the market on a promising new approach to addressing pet euthanasia.

What is Chemical Sterilization? Historically, many hazardous chemicals (e.g., Chemcast) have been used to sterilize male mammals, including dogs and cats. Some actually dissolved the entire testis over time (chemical castration or chemical neutering), making it equivalent to castration. Unfortunately, most of these methods cause tremendous suffering and serious reactions for the animals.

Zinc Gluconate (What is Zinc Gluconate? ) neutralized with L-Arginine (What is L-Arginine?) is the first compound ever to be approved by the FDA as safe for such sterilization. It uses Zinc Gluconate (a trace element) and Arginine (an amino acid), both of which are essential for the body. In fact, they are health supplements that millions of us use every day.

A specific concentration of Zinc Gluconate neutralized with Arginine creates permanent sterilization with no adverse reactions needing medical treatment nearly 99% of the time (see the question on side effects below for other minor reactions). The mechanism is so targeted and precise that in an FDA study, it virtually stopped spermatogenesis in 99.6% of young dogs 3-10 months old, rendering them sterile, while maintaining the endocrine function of the testes.

What is zeutering? Short for Zinc Neutering. It is a non-surgical procedure that permanently sterilizes male mammals using Zinc as the active spermicide.

How does Zinc Gluconate neutralized with Arginine sterilize a male dog? After the injection, the Zinc-based solution diffuses in all directions from the center of the testis. The specific concentration of Zinc (a gentle spermicide) used in our formula destroys spermatozoa in all stages of maturation in the seminiferous tubules and in the epididymis. The seminiferous tubules, which were replete with spermatozoa, are now emptied and collapse.

The dog's body increases blood flow and creates inflammation to heal. Within days, scar tissue (or fibrosis) from the healing process creates blockages in the seminiferous tubules, and more importantly, in the rete testis (the part of the testis that feeds the epididymis). All sperm must finally pass through these feeder tubules, which are now effectively closed as a result of the specific location of the injection. Zinc Gluconate and Arginine are absorbed and metabolized by the body. The male dog is now safely sterilized for life.

Leydig cells (cells responsible for the endocrine function of the testes) survive the procedure, since the Zinc Gluconate neutralized with Arginine™ formulation is non-toxic. Hence, the critical endocrine function of the testes remains intact. Over time, the seminiferous tubules, rete testis, epididymis, and prostate all atrophy--reducing the size and changing the texture of testicles.

What age should the dog be for the procedure? Esterilsol is approved for all ages by SAGARPA in Mexico. We will be demonstrating it for all ages during our training days using the Mexican product. We expect Esterilsol to be US FDA approved as safe for all ages over three months before our final product release date in 2012. A separate study to establish safety at 8 weeks of age is being initiated. Ark Sciences has full rights to Neutersol, the Zinc Gluconate neutralized with Arginine brand name that is US FDA approved for dogs 3-10 months old.

When does the dog become sterile? The sterilization procedure effectively shuts down sperm production within 1 to 3 days.  However, sperm in the vas deferens and possibly the epididymis can reside for up to 30 days.  Hence, a sexually mature dog treated with Zinc Gluconate neutralized with Arginine could potentially impregnate a female up to 30 days post injection. Note that vasectomies and castrations can leave some sperm in the vas deferens remnants for up to 21 days.

Is Zinc Gluconate neutralized with Arginine safe? Yes, the FDA clinical trial for Neutersol established its safety. This zinc formulation used in a specific concentration at a specific location in the testis creates the specific result of sterilization in seconds. Ultimately, it is the FDA approval that assures us all that Zinc Gluconate neutralized with Arginine is safe and effective.

The FDA Approval Study, several follow-up studies, and field trials all have established that Zinc Gluconate neutralized with Arginine can safely sterilize a dog and reduce its testosterone levels by about half using this non-invasive and virtually painless (hard to believe but true) injection.

Are there any preservatives in your formulation? No. Our formulation does not contain any preservatives. Simply discard any unused product 6 hours after first needle insertion into the vial to avoid complications due to possible product contamination.

What are the side effects? While adverse reactions requiring medical treatment occurred in only 1.1% of the dogs, there were minor reactions observed in 6.3% of dogs during the FDA study. Local reactions included testicular swelling (normal reaction to the injection), pain (dogs may resist sitting or may sit with both hind legs open), biting and licking at the scrotum, swelling of the prepuce and irritation, dermatitis, ulceration, infection, dryness or bruising of the scrotum. Systemic reactions included an increase in the white blood cell count, vomiting, anorexia (loss of appetite), lethargy (tiredness or abnormal attitude), and diarrhea.

Most reactions were seen within the first 7 days after the injection. Over 80% of dogs did not show any signs of post procedure pain. When pain was detected, it was most commonly seen in the first 2 days. No pain management medications were used in the study. Vomiting was most commonly seen on the day of the injection (within 1 minute and 4 hours after the injection). It is recommended to withhold food for 12 hours prior to injection to help prevent vomiting, which occurred in 4% of dogs. Your dog's testicles may remain slightly enlarged but non-painful for a few months after the injection. Proper injection technique and owner observation post-injection is critical to avoid any potential undesirable side effects.

Are there any studies on long-term side effects? Yes, we followed 40 dogs for over two years and have data on many of these dogs for over 5 years.  Since 1999, when the initial clinical studies were performed, there have not been any reports of long-term side effects.

Does this sterilization procedure increase or decrease the risk for testicular cancer? Long-term observations have shown no increase in risk for testicular cancer. However, no studies have been performed to evaluate if Zinc Gluconate neutralized with Arginine decreases the risk of testicular cancer.

What happens physically to the testicles? During the procedure, a single injection of Zinc Gluconate neutralized with Arginine is administered directly into each testicle. Following the procedure, over time, the testicles generally shrink and change texture due to fibrosis.

Will the dog look intact after the procedure? Yes. Cosmetic testicular implants like Neuticles should not be needed or used.

How can an injection into the testicles be "virtually painless"? What is unusual and not generally known about the physiology of the testes is that there are no pain sensors inside the testes, only pressure sensors. Ark-certified vets are specifically trained to deliver the injection very slowly to avoid triggering the pressure receptors. Indeed, 97.5% of dogs (76% not even sedated) did not show any signs of distress during the procedure.

Surely, any needle inserted through the skin will cause pain for an instant. However, the needle used for this procedure is a very fine 28 gauge needle that people over forty may even find hard to see, minimizing the pain caused.

How does zeutering affect testosterone levels? Studies have shown that testosterone production decreases 41-52% in treated dogs. The reduction is permanent.

How is testosterone lowered by Zinc Gluconate neutralized with Arginine? The dosage and concentration is designed to ensure Leydig Cells in the interstitial space of the testes survive the procedure. Stimulated by Luteinizing Hormone (LH) produced in the pituitary gland, the Leydig Cells continue to support testosterone-related metabolic activity and growth. In the absence of spermatogenesis, Sertoli cells stop communicating the need for testosterone to mature sperm cells. The pituitary gland detects this lowered demand and lowers the LH levels. Since LH levels determine how much testosterone is produced by the Leydig cells, overall testosterone levels are reduced by 41-52% for all dogs.

Does this procedure have any effect on behavior? The FDA approved the following statement for Neutersol: "As with surgical castration, Neutersol™ may not eliminate male behavior such as roaming, marking, aggression, or mounting in dogs." Anecdotal information collected from dog owners shows that such sterilization does suppress mating behaviors very much like castration. We are currently conducting a study in Chile to answer this question on a scientific basis.

Studies conducted to date on dog behavior impact from surgical castration in dogs show only an effect on roaming and urine marking.   In fact, there is emerging evidence that in pursuit of mating behavior suppression, castration may actually cause other undesirable behaviors to emerge. It is the opinion of several leading behavioral scientists that Zinc Gluconate neutralized with Arginine will have effects on mating behaviors similar to those observed with surgical castration. Furthermore, to the extent the undesirable behavior changes related to castration are caused by the complete elimination of testosterone, Zinc Gluconate neutralized with Arginine sterilization would be unlikely to manifest such changes.

Any known benefits/risks for senior dogs? Benefits: Avoid anesthesia/surgical procedure and maintain hormone function. Risks: No known additional risks

Are there any case studies on your products? Yes. Here is a compilation of reports that have been published. Read the report.

Why do adverse reactions (beyond side effects) occur in 1.1% of treated dogs? There are some misconceptions about this procedure being "dangerous" and that Zinc Gluconate and Arginine create some acid-like deadly combination. The truth is that this combination has the same pH as water (i.e. 7), will not irritate normal skin, and over 98% of dogs do not need any medical attention after the procedure.

The adverse reactions have several causes:

1. Undetected scrotal dermatitis during the screening exam (sometimes hidden by thick scrotal fur because it is not shaved) combined with even a small product spill during the injection.
2. Fast injection speed leading to testis contraction, creating product spill into the scrotum.
3. Improper site entry or needle size leading to product diffusion outside the testis.
4. Incorrect dosage determination leading to product diffusion outside the testis.
5. Testicular abnormalities or a rare allergic reaction to ingredients may also be possible

Any of these issues can cause an itch or irritation in the scrotum causing the dog to lick and bite as there is no E-collar in place after sterilization. If the dog is not monitored to prevent the licking and biting, serious irritation, infections, and/or ulcers can result. Most of these conditions can be treated with topical ointments. In rare cases, scrotal ablation or castration may become necessary.

In free roaming or poorly maintained dogs (depending on the shelter), scrotal dermatitis is more common, and after care may not be possible, hence the rate of adverse reactions and severity is seen to be higher in these populations.

As new organizations embark on the use of Zinc Gluconate neutralized with Arginine, they should expect to treat 1-2 dogs with topical ointment for every 100 dogs sterilized and handle one scrotal ulceration needing scrotal ablation and possible castration. Most scrotal irritations observed during the first 3 days heal on their own unless the dog starts to lick and/or bite the area.

Experience shows that there may be a learning curve for vets in handling these adverse reactions effectively. A hot line will be established for support and record keeping. Over time these rates should reduce to 1-2 dog needing any medical attention for every 100, which is the rate observed in controlled studies in the US environment (rates observed in rural Mexico were much higher due to the condition of the dogs). Such costs should be factored in to determine overall savings for the non-profit organization.

How do I minimize adverse reactions? To minimize the occurrence of adverse reactions, such as scrotal irritation, inflammation or infection, it is critical that you closely monitor your dog's activity post-injection and that you take all precautions necessary to prevent injury to the testicles and to prevent your dog from licking or biting the scrotal area. Restrict your dog's exercise to leash walking; not allow your dog to run, jump, or engage in play activity; not allow your dog to lay on hard or wet surfaces; not allow your dog to lick or bite the scrotal area.

When to choose non-surgical neutering over castration?
Barring few exceptions, we should be sterilizing all our pets to end the needless suffering and euthanasia due to the overpopulation of our dearest companions. A non-invasive procedure like Zinc Gluconate neutralized with Arginine should always be the first procedure considered as it does not prevent a castration later, if so desired for any reason.

For dog breeds more susceptible to complications from anesthesia (e.g., brachycephalic breeds like Pugs, Pekingese, Bulldog, etc.) or for dogs compromised in any way and at higher risk of anesthesia death, Zinc Gluconate neutralized with Arginine is the only humane option.

In the hands of an experienced practitioner, this non-invasive injection is faster, gentler, safer, and cheaper than castration. Zinc Gluconate neutralized with Arginine will sterilize the dog and eliminate testosterone needed to support spermatogenesis, while preserving testosterone needed for other metabolic functions, a roughly 41-52% permanent reduction. While retaining some testosterone has beneficial effects, this procedure may not reduce the risks of diseases associated with male hormones, such as prostatic disease or testicular or perianal tumors in dogs. For many dog breeds and individuals with genetic predispositions, castration may seriously compromise long-term health due to near elimination of testosterone in the body.

There is little scientific evidence that castration for testosterone elimination creates desirable behavior changes. Much like Zinc Gluconate neutralized with Arginine sterilization, it may suppress mating behaviors around a female in estrus. However, there is emerging evidence that in pursuit of mating behavior suppression, castration may actually cause other undesirable behaviors to emerge.

Side-By-Side Comparison of Castration and Zeutering

Is Zinc Gluconate neutralized with Arginine more expensive than surgical castration?
It should not be. Based on the Ark's potential offer to non-profits in the US, the cost of non-surgical sterilization will be 1/5th the cost of castration (on average). However, the real value of this technology becomes apparent when you consider your dog’s safety (1 in 1,849 healthy dogs die from anesthesia complications), long-term health, and behavior.

What is the connection between Neutersol and Esterilsol™?
Neutersol and Esterilsol™ use the same mineral compound (Zinc Gluconate neutralized by Arginine) Neutersol is approved by the US FDA as safe and effective for use in 3-10 month dog sterilizations. Neutersol was distributed by Addison Labs starting in 2003 for about three years. Ark Sciences has acquired all rights to the Neutersol technology

Esterilsol is Ark Sciences' product for international markets. Esterilsol™ is now registered in 4 countries and pending approval in key markets around the world. It is approved for all dogs over 3 months of age in Mexico. Over the last four years, Ark Sciences has utilized Esterilsol™ extensively in Mexico in dogs three months and older to assess its efficacy as well as refining and improving the injection technique to minimize reactions.

In early 2011, Ark Sciences having acquired full rights to the intellectual property for Neutersol, it started to set up manufacturing at a facility located in Albuquerque, New Mexico. This manufacturing facility is expected to be FDA approved in 2012. Ark Sciences is planning to launch its international product Esterilsol™ for all dogs over 3 months old in the US in 2012 pending FDA approval. Initial focus will be on non-profit animal shelters and high volume spay/neuter clinics at a game-changing low price.

What happened to Neutersol?
Encouraged by the enthusiastic response and media attention in 2003, Addison Labs, the exclusive distributor of Neutersol, overestimated the growth in demand and created too much inventory. The excess inventory expired in two years and the manufacturer went unpaid, shutting down production. Finally, the manufacturer severed its relationship with the distributor.

Why did you not win the Found Animals Michelson Prize of $25M for your technology?
The Michelson Prize is to license a technology that works on male and female dogs and cats. Our technology is only for male dogs and cats and not available for licensing.

Why did you develop a product only for males?
Dr Wang, the co-inventor, wanted to come up with a solution that did not create system-wide reactions or imbalance. This objective eliminated most approaches that can usually be applied to both males and females. The localized effect of Zinc targeted at sperm cells, and sperm cells alone, makes it a safe and permanent sterilant.

How do I get my dog sterilized with Zinc Gluconate neutralized with Arginine?
Most animal centers or shelters will have trained vets doing sterilizations starting May 2012. For privately owned dogs, you can request Ark Sciences to send an offer to your dog's vet to get certified. You can do this by getting on the Ark waiting list. The waiting list will be cleared on a first-come first-served basis when the product becomes available.

Is there any way to verify that the procedure has been done correctly? Efficacy rate is documented at 99.6% but the only way to know for sure that the dog is sterile is for the vet to test the dog semen after 30 days. Also, when the procedure is done correctly, dogs should experience no adverse reactions needing medical attention.

How do you identify a treated dog? Leading microchip companies are capable of keeping neutering status in their databases. Tattooed serial numbers can also be used if a microchip is not practical. This will prevent the dog from being castrated if rescued at a later date.

During the "training period" starting in November, we will use an optional "Z" tattoo next to the scrotal area. It will be formed using a tattoo pen next to the scrotum. Since this would be the most invasive part of the whole sterilization procedure, we will have to analyze the results to see if this method will survive as a standard practice. Veterinarians familiar with the sterilization procedure will also be able to tell if a dog has been sterilized after a few months by palpating the testicles--the testicles become smaller and firmer as scar tissue forms over time.

Many dog owners are understandably concerned about onlookers and "dog run" friends giving them the evil eye--assuming their anatomically correct male dog is intact. To address this concern, we are finishing up final designs on collar add-ons and fun T-shirts for sterilized but not castrated dogs to flaunt their special status.

Can veterinarians sign sterilization certificates for treated dogs? Yes. Sample certificates are available on request.

I’m a vet. How do I learn to use your product?
This product is only available to licensed veterinarians who are trained in the Ark injection technique. We are scheduling a limited number of private vets to be trained at our Training Facilities. Please contact us you are interested in getting trained.

Do you have to be a licensed veterinarian to sterilize using your product? More than that, it must be administered by a veterinarian or a vet tech under the supervision of a licensed veterinarian. Further, each vet or vet tech must be fully trained by Ark Sciences prior to administering Zinc Gluconate neutralized with Arginine.

Why do you have such a strict training and data collection protocol? Is the procedure prone to errors? No. Once the vet is trained, errors are uncommon. Adverse reaction rates in the FDA study and in field trials are substantially lower than castration even without a tight training protocol. It became clear from our FDA study and other field experiences that even the low 1.1% adverse reaction rate (ones that required medical treatment) could be reduced down to almost zero if the injection technique is well understood and followed. Improvements from 90% to 99% are much easier than going beyond 99%--hence our intense focus on the procedure and data collection to get real-time feedback. Our goal is to create a near perfect track record of our procedure as each and every dog is important to us.