We are a wellness consumer products company. We offer several over-the-counter,
or (OTC) and cosmetic, consumer products. Our method of operation is to ensure
that (1) the mechanism of action of all products is established, (2) efficacy is
determined through controlled clinical trials, (3) products are protected by
issued and filed patents, and (4) products have acceptable commercial stability.
Prior to its Q3 2022 commercial launch in India as a treatment for vitiligo and
psoriasis, Photocil was briefly launched in the United States markets from
December 2022 until February 2023, however, was subsequently removed from the
market due to insufficient sales resulting from the lack of a dedicated sales
and marketing team. We are currently preparing for its relaunch in the United
States, which is targeted for 2025, as we explore manufacturing and marketing
options. The product formulation has not been changed since its removal from the
US markets, and no changes to the formulation are planned for the proposed U.S.
market relaunch. Photocil is a narrow band UV filter that focuses UV in the
311nm range which is therapeutic for vitiligo and psoriasis. Dimethicone, also
called polymethylsiloxane, is a silicon-based polymer used as a lubricant and
conditioning agent. It is the USP (United States Pharmacopeia, which is the
official compendium of standards for medicines and healthcare products in the
United States) monographed ingredient in Photocil. Dimethicone is used to create
a smooth feel and a water-resistant barrier on the skin. In addition to
dimethicone, Photocil contains two UV filters that restrict the band width of UV
rays on the skin to a narrow-range ~ 308 nm. This narrow-band UV has therapeutic
properties. These proprietary technologies are not found in other sunscreens and
Photocil does not contain conventional UV blockers found in the majority of
sunscreens. The product is categorized as an OTC product in the United States,
using an USP monographed ingredient as a skin protectant, with FDA-registered
labeling (USP monographed: A reference to ingredients listed in the United
States Pharmacopeia (USP), which is the official compendium of standards for
medicines and healthcare products in the United States). Photocil does not
require FDA pre-market approval as it uses GRASE (Generally Recognized as Safe
and Effective) ingredients and is currently marketed in India under local
cosmetic regulations. Photocil is a cosmetic product designed to block certain
UV radiation while allowing other UV radiation to pass through when applied to
the skin. The product contains ingredients that are listed in the USP monograph
for skin protectants. As a cosmetic product, Photocil has not been evaluated by
the FDA for safety and effectiveness. The product contains ingredients that are
listed in the USP monograph for skin protectants and is marketed as a cosmetic
product in compliance with FDA regulations for cosmetics. The Joint American
Academy of Dermatology and National Psoriasis Foundation guidelines for the
management and treatment of psoriasis with phototherapy, published in JAMA
Dermatology in 2019, strongly recommend narrow-band UVB phototherapy as a
monotherapy for treating plaque psoriasis in adults, supported by a systematic
review and meta-analysis of 41 randomized controlled trials involving 2,416
patients.
Phototherapy
Management believes that phototherapy treatments, used for conditions such as
psoriasis and vitiligo, are set for substantial growth globally. However, there
can be no guarantees that this growth will materialize as expected, as it is
subject to various market conditions, regulatory developments, and other
external factors beyond the Company’s control. Specific market data focused
solely on the Indian phototherapy treatment segment is limited, and the
available market data focuses primarily on phototherapy devices. However,
according to Future Market Insights (2023)(1), the Indian market is expected to
experience strong growth, driven by the rising prevalence of skin disorders,
increased healthcare spending, and improved access to treatment in both urban
and rural areas.
According to Future Market Insights (2023), the global phototherapy treatment
market is projected to rise from ~ USD $1.9 billion in 2023 to ~ USD
$3.23 billion by 2033, at a CAGR of around 5.2% during the forecast period from
2023 to 2033. In India, the market is expected to expand even faster, with an
estimated CAGR of approximately 7.8% as of 2023, driven by a large patient base,
increasing prevalence of skin disorders, greater awareness of noninvasive
treatments, and improved healthcare infrastructure (Future Market Insights,
2023).
Psoriasis
According to a report by Nature Reviews Drug Discovery (2024)(2), the global
psoriasis treatment market was worth ~ $34 billion globally in the 12 months
ending June 2023. The report shows the US remains the dominant market for
psoriasis therapies, accounting for approximately 78% of total sales and growing
at a compound annual growth rate of approximately 18%.
According to the same report (Nature Reviews Drug Discovery, 2024), with the
current growth rate (CAGR of 8–10% from 2023 to 2030), the global market is
expected to reach ~ USD $54-67 billion by 2030. Estimates from a report
published on the National Center for Biotechnology Information(3), indicate that
the prevalence of psoriasis in India ranges from 0.44% to 2.8% of the
population, highlighting Management’s belief in the significant market
opportunity in India. However, actual market growth may be influenced by factors
such as regulatory changes, competition, and economic conditions, which could
impact the overall demand for psoriasis treatments. Management believes that
Psoriasis treatment with Photocil may only address a very small fraction of the
market in the US and India. However, actual market penetration will depend on
various factors, including the development of a dedicated sales and marketing
team at Caring Brands, market demand, competitive landscape, and regulatory
considerations. There can be no assurance that these efforts will result in
significant market adoption.
Vitiligo
According to a report by Expert Market Research (2024)(4), the global vitiligo
treatment market was valued at ~ USD 538.90 million in 2024. The global market
is projected to grow at a compound annual growth rate (CAGR) of 4.60% from 2025
to 2034, reaching ~ USD 807.70 million by 2034 (Expert Market Research, 2024).
According to Expert Market Research (2024), this growth is attributed to the
increasing global prevalence of vitiligo and the rising demand for effective
treatments, and Management believes that these factors may contribute to
expanding market opportunities. However, actual market expansion may be
influenced by factors such as regulatory changes, competition, and advancements
in alternative therapies, which could impact the overall demand for vitiligo
treatments.
According to the report by Expert Market Research (2024), the US market is
expected to remain the dominant market for vitiligo treatments. The report also
states that the Asia Pacific region is expected to witness the fastest growth
during the forecast period due to increasing awareness, emerging treatment
options, growing research and development activities, and favorable government
initiatives in developing nations. As part of this Asia Pacific region,
management believes India presents a potential opportunity for market expansion.
However, there is no certainty that this growth will materialize as expected, as
it depends on various external factors, which will impact the overall demand.
As per reports published on the National Centre for Biotechnology Information(5)
(6), across studies from India, the prevalence of vitiligo has consistently been
reported to be between 0.25%-4% (Cureus Report)(5) and can reach as high as 8.8%
of the population in certain regions like Gujarat and Rajasthan (Indian Journal
of Community Medicine)(6), making India a highly affected region globally.
However, even though Management believes that this presents a potential market
opportunity, Vitiligo treatment with Photocil is expected to address only a very
small fraction of the total global market. Future market penetration is
uncertain and subject to factors such as regulatory approvals, competitive
dynamics, and effective marketing strategies. There can be no assurances that
Photocil will achieve meaningful adoption in the market.
Our licensee in India, Cosmofix and San Pellegrino Cosmetics, is currently
exploring additional sub-licensing opportunities in Nepal, Bangladesh, Sri
Lanka, Vietnam, Philippines, Malaysia, Cambodia, Laos, Indonesia, UAE, Egypt,
Algeria, Tunisia, Congo, Nigeria, Kenya, Thailand, Bahrain, Iran, Iraq, Jordan,
Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, and Saudi Arabia. We are also in
preliminary discussions regarding potential licensing opportunities in Europe
and South America, though no formal agreements are currently in place. The
results of clinical trials on Photocil have been published in Expert Opin
Pharmacother, including 2014 Dec;15(18):2623-7; Dermatol Ther. 2014
Jul-Aug;27(4):195-7; Dermatol Ther. 2014 Sep-Oct;27(5):260-3. In July 2021,
Safety Shot (then Jupiter Wellness) obtained an exclusive license from Applied
Biology Inc. to manufacture and sell Photocil. Subsequently, in June 2022,
Safety Shot (then Jupiter Wellness) acquired all assets of Applied Biology Inc.,
including Photocil, through an asset purchase agreement. The product was
commercially launched in India in September 2022 under a licensing agreement
with Cosmofix and San Pellegrino Cosmetics and entered the U.S. market in Q4
2022 via Amazon. However, it was removed from the U.S. market in February 2023
due to insufficient sales resulting from the lack of a dedicated sales and
marketing team. In India, Photocil is currently marketed as an OTC product
compliant with local regulatory standards. In the United States, it was
previously commercialized with FDA-registered labeling as a Jupiter Wellness
product. We plan to apply for a National Drug Code (NDC) number for FDA
registration prior to relaunching the product in the U.S. market. Photocil has
been evaluated in clinical trials for the treatment of vitiligo and psoriasis,
demonstrating significant efficacy.
Our Hair Enzyme Booster (JW-700), previously known as Minoxidil Booster, was
initially developed by Applied Biology Inc. and was acquired by Safety Shot
(then Jupiter Wellness) in June 2022 through an asset purchase agreement. The
product received labelling approval as a cosmetic from the Central Drugs
Standard Control Organization (CDSCO) and is currently being manufactured and
sold in India through our agreement with Cosmofix and San Pellegrino Cosmetics.
Hair Enzyme Booster (JW-700) was launched on Amazon on October 28, 2024, and
became available on NOVODX’s e-commerce platform on December 11, 2024. As of the
date of this prospectus, the Hair Enzyme Booster (JW-700) continues to be sold
on both platforms.
The Hair Enzyme Booster has been clinically shown to increase the enzymes needed
for minoxidil (an FDA-approved over-the-counter medication used to treat hair
loss and promote hair regrowth) to work, sulfotransferase enzymes, by using the
product topically in conjunction with topical minoxidil. The Hair Enzyme Booster
(JW-700) is marketed and sold as a cosmetic product in the U.S., containing
GRASE ingredients that do not require FDA pre-market approval and complying with
FDA labeling requirements. In India, it is currently marketed under local
cosmetic regulations. The Company launched the Hair Enzyme Booster (JW-700) in
the U.S in the fourth Quarter of 2024. The product is designed to improve
Minoxidil efficacy and is available as a topical solution. It is designed to
enhance the efficacy of minoxidil by increasing necessary enzyme levels and must
be used in combination with FDA-approved minoxidil products. JW-700 does not
independently treat hair loss or promote hair regrowth. Clinically shown to
increase the sulfotransferase enzyme needed for minoxidil to work, has 2 granted
and 5 pending patents.
Minoxidil market was valued at $1.5 billion in 2022 and is expected to grow to
$2.5 billion by 2032. Licensed to Taisho, a $2.6 billion revenue company and
Japan’s leading seller of minoxidil products. They expect to launch the product
commercially in 2025. The term of the Taisho License is for five (5) years with
an automatic renewal of one (1) year unless terminated otherwise. As
consideration, Caring Brands shall receive up to $200,000 in milestone payments
and a 3% royalty subject to the terms and conditions of the Taisho License. On
September 1, 2022, Safety Shot (then Jupiter Wellness), entered into a license
agreement with Cosmofix and San Pellegrino cosmetics to market and manufacture
the Hair Enzyme Booster (JW-700) and Photocil for the Indian market and 31 other
companies in Africa and Far East. The license is for three years with an
automatic renewal of one(1) year unless terminated otherwise. Photocil and the
Hair Enzyme Booster (JW-700) are being sold in India. As consideration a 3%
royalty subject to the terms and conditions of the Cosmofix/San Pellegrino
license. The License was transferred to the Company, pursuant to the Separation
and Exchange Agreement (as defined below). The Company launched the Hair Enzyme
Booster (JW-700) in the US in 4Q, 2024. As the product contains components that
are generally regarded as safe (GRASE) it does not require FDA approval.
Clinical studies on the Hair Enzyme Booster (JW-700) have been published:
Journal of Cosmetic Dermatology (2022), Vol.21, Issue 4, 1647-1650. The Hair
Enzyme Booster (JW-700) has undergone multiple clinical trials, demonstrating
its potential efficacy in treating androgenetic alopecia (AGA). The Hair Enzyme
Booster (JW-700) is designed to enhance the efficacy of minoxidil by increasing
necessary enzyme levels and must be used in combination with FDA-approved
minoxidil products. The Hair Enzyme Booster (JW-700) does not independently
treat hair loss or promote hair regrowth.
CB-101 treatment for Atopic Dermatitis (Eczema) is a topical over-the-counter
treatment for atopic dermatitis (eczema) with dual-action relief from aspartame
(ASN or artificial sweetener being used in a new formulation for skin treatment)
and colloidal oatmeal (an FDA-approved ingredient for skin protection and relief
of minor skin irritations). In clinical studies of the prior formulation
(containing CBD), JW-100 cleared or reduced eczema following 2 weeks of use and
may prove potentially superior to existing prescription drugs. It currently has
4 pending patents, with the global eczema treatment market valued at $14 billion
in 2022. 31.6 million Americans, or 10% of the population, have eczema; 86% are
not satisfied with their treatment and want more and better treatment options.
CB-101 eczema treatment is currently undergoing reformulation, which we expect
to complete in Q1/Q2 2025, and it is anticipated to be available online in the
US in the third quarter of 2025 as an over-the-counter product under a USP
monograph. CB-101 will be marketed as an OTC product under the applicable USP
monograph. It contains colloidal oatmeal, which is covered under the USP
monograph for skin protectant products. The product will comply with all
requirements outlined in the applicable USP monograph and will require FDA
registration and an NDC number prior to marketing. The clinical study on JW-100
was published in the Journal of Cosmetic Dermatology, Vol. 21, Issue 4, April
2022, pp: 1647-1650. The primary endpoint of this research was a reduction in
the Investigator’s Static Global Assessment (ISGA) score. The treatment group
achieved an average ISGA score reduction of 1.28 compared to 0.70 in the placebo
group (p=0.042). Additionally, 50% of subjects in the treatment group achieved
an ISGA rating of “clear” or “almost clear” with a two-grade improvement,
compared to 15% in the placebo group (p=0.028). No adverse events were reported
during the study. The original formulation, JW-100, contained CBD as an active
ingredient, while the new formulation, CB-101, removes CBD, while maintaining
aspartame (ASN) and introducing colloidal oatmeal as key ingredients. This
dual-action formulation is designed to provide relief from eczema symptoms and
allows the product to be marketed as an OTC product under a USP monograph for
skin protectants. The reformulated product retains the therapeutic approach of
the original while utilizing ingredients compliant with applicable USP
monographs. The development process is currently in the final stages, with
$150,000 allocated to completing formulation development, $200,000 planned for
the initial production run, and $50,000 for clinical testing. The target launch
date for the product is Q4 2025.
NoStingz is currently being re-formulated under Caring Brands as a sunscreen
product designed to provide protection against both UV rays and jellyfish
stings. NoStingz was previously commercialized in the United States market from
July 2022 and was removed from the market in September 2023 due to insufficient
sales resulting from the lack of a dedicated sales and marketing team. The
previously commercialized version contained FDA-compliant sunscreen active
ingredients, and we are currently reformulating the product and conducting
stability testing. All actives will meet the USP specifications mandated by the
FDA in its sunscreen monograph. The new formulation, which is currently in
development stages, is exploring a combination of rubidium iodide and menthol,
which has demonstrated promising results in a small trial conducted in the
Florida Keys.
Trial Details
The trial was conducted from May 29 - June 17, 2023, in Key West, Florida to
evaluate the efficacy of NoStingz formulations against Portuguese man-o’-war
(Physalia physalis) stings. The study was conducted by independent researchers
who collected specimens from Atlantic waters near Key West.
Methodology and Design
The researchers developed a controlled, blind testing protocol using preserved
Portuguese man-o’-war specimens collected from the Atlantic waters near Key
West. The methodology involved carefully preserving the stinging tentacles
through a controlled dehydration process, followed by systematic rehydration of
small portions for standardized testing applications. The study evaluated
multiple formulation types, including mineral-based sprays and lotions with SPF
levels of 30 and 50. To ensure scientific validity, the researchers incorporated
placebo controls using untreated skin areas. The evaluators assessed sting
responses and protective efficacy of the different formulations against the
control areas.
Results and Safety
The combination of rubidium iodide and menthol demonstrated promising initial
results in reducing sting severity. However, we note that this was a small
preliminary trial and further testing is needed to establish statistical
significance. No adverse events or safety concerns were reported during the
trial period.
Mechanism of Action
Rubidium iodide and menthol were selected based on their potential protective
properties:
. Rubidium iodide acts as a potential inhibitor of the nematocyst discharge
mechanism
. Menthol provides a cooling sensation and may help reduce localized
inflammatory response
We are currently conducting additional stability testing and formulation work
before proceeding with larger scale trials to validate these preliminary
findings. The reformulated product is designed to provide dual protection
against both UV rays and jellyfish stings. We have not yet established a
timeline for commercial launch. As the product contains ingredients with
well-established safety profiles, it does not require FDA approval. NoStingz
will be regulated as a sunscreen product and will comply with the FDA’s
sunscreen guidelines. It will contain FDA-approved sunscreen active ingredients
and will require FDA registration and an NDC number prior to marketing.
Our products are tested for quality and stability each time they are
manufactured. One of our manufacturers is Stella Industries Ltd., Haryana,
India, which manufactures the Hair Enzyme Booster (JW-700) and Photocil for the
Indian market. Stability on commercial batches manufactured in India indicates a
shelf life of at least 24 months. Stella Industries is compliant with the FDA’s
Current Good Manufacturing Practice, or CGMP, regulations in accordance with 21
CFR 210/211 required for over-the-counter drug products. It is ISO-9001
certified. Another manufacturer is DCR Labs, Daytona Beach, Florida, which is
also fully compliant with the FDA’s Current Good Manufacturing Practice, or
CGMP, for cosmetic products.
We expect to continually update and expand upon our corporate website and
further refine our online retail strategies on an ongoing basis.
CaringBrands.com is our primary corporate website, which will serve as the
primary source of information about us for investors and will contain press
releases, clinical trial pipeline, lab reports, blog posts, and additional
information about each of our brands. We have built an e-commerce platform
designed to connect us directly to consumers. We use the platform to sell
products, educate customers, and build brand loyalty.
1. Future Market Insights (2023) – Phototherapy Treatment Market:
https://www.futuremarketinsights.com/reports/north-america-and-europe-phototherapy-treatment-market
2. Nature Reviews Drug Discovery (2024) – The Pipeline and Market for Psoriasis
Drugs, Vol. 23, Issue 7, Pages 492-493. Doi:
https://doi.org/10.1038/d41573-024-00018-2
3. National Center for Biotechnology Information:
https://pmc.ncbi.nlm.nih.gov/articles/PMC4252960/ Kumar S, Nayak C., Padhi T,
et al. (November, 2014). Epidemiological pattern of psoriasis, vitiligo, and
atopic dermatitis in India: A hospital-based point prevalence. Indian
Dermatology Online Journal, 5(Suppl 1), S2–S8. Doi: 10.4103/2229-5178.144499
4. Expert Market Research (2024) – Vitiligo Treatment Market:
https://www.expertmarketresearch.com/reports/vitiligo-treatment-market
5. National Center for Biotechnology Information:
https://pmc.ncbi.nlm.nih.gov/articles/PMC11112533/ Saha D, Roy S, Ahmed R, et
al. (April 23, 2024). Clinico-Epidemiological Profile of Vitiligo Among
Patients Attending a Tertiary Care Centre of North-East India. Cureus
16(4): e58804. doi:10.7759/cureus.58804
6. National Center for Biotechnology Information:
https://pmc.ncbi.nlm.nih.gov/articles/PMC4134529/ Vora R V., Patel B.,
Chaudhary A.H., et al. (July – Sept 2014). A Clinical Study of Vitiligo in a
Rural Set up of Gujarat. Indian Journal of Community Medicine
39(3):p 143-146, Jul–Sep 2014. Doi: 10.4103/0970-0218.137150
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Our principal executive offices are located at 1061 E. Indiantown Road, Suite
110, Jupiter, Florida and our telephone number is (561) 896-7616. Our website
address is www.Caringbrands.com.
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