The Stork Ib2c, Inc, a Rinovum Women's Health Company

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PRESS RELEASE – DRAFT CONTACT: Brianna Clements, The Stork Ib2C, Inc, A Rinovum Women’s Health Company 724-241-8936 [email protected] The Stork Ib2C, Inc, A Rinovum Women’s Health Company, Bridging the Gap for Women With Limited Access to Fertility Services and Local Clinics The Stork® OTC offers solution to findings revealed in a recent study showing reproductive-age women need better access to at-home fertility treatment options PITTSBURGH, Pa., April 19, 2017– While fertility clinics may be difficult for some women to access, there are other more accessible options. Pittsburgh-based medical device company, Rinovum Women's Health, offers solutions for building families naturally with an at-home conception device designed to help with becoming pregnant. This innovative alternative can be especially helpful for the nearly 40 percent of reproductive-age women in the United States with limited or no local access to assisted reproductive technology clinics. The Stork® OTC (www.storkotc.com) is an FDA-cleared over-the-counter treatment device designed to optimize the chances of at-home conception using the cervical cap insemination technique. It is a safe, easy-to-use, accessible treatment option to help women become pregnant during ovulation without a prescription and in the privacy of their own home. According to a recent study published in the journal Fertility & Sterility, 25 million reproductive-age women in the United States have limited or no access to assisted reproductive technology (ART) clinics, which provide services that are vital to many women trying to become pregnant. The study used data from the Centers for Disease Control and Prevention to pinpoint infertility clinics in proximity to where women live in order to evaluate and assess viable access to infertility care in the United States. “The Stork OTC is a uniquely designed medical device that has helped many couples come closer to their goal of building a family. It’s an easy-to-use, drug-free, cost- effective way to take control and optimize your chances to conceive without driving to distant clinics,” explained Dr. Michael J. Pelekanos, Board Certified OB/GYN based in Monroeville, Pa. ART-0523 R01 This type of treatment has been used effectively in the professional setting, but now it’s readily available to couples at home. The Stork OTC can be used for common fertility issues in both men and women including: ● Couples with unexplained infertility ● Men with low sperm count or low sperm motility ● Women with unfavorable vaginal environment (pH imbalances) ● Couples trying to become pregnant without having intercourse The Stork OTC is available for purchase at select retailers nationwide and online for the average retail price of $79.99, making it more accessible and less expensive than other first-line options for all couples trying to conceive. To learn more about how The Stork OTC works, watch the full video here. For more information and retailer and online availability, as well as pregnancy stories, visit www.storkotc.com. About The Stork Ib2C, Inc., A Rinovum Women’s Health Company Rinovum Women's Health is a privately held women's health company dedicated to bringing products into the market that will enhance women's lives and empower them to take charge of their health. The Stork Ib2C, Inc., A Rinovum Women’s Health Company, launched its flagship product, The Stork® OTC, which is a conception device for reproductive health to assist in natural fertility and conception in the privacy of the patient’s home. Rinovum Women's Health aims to support the development of products that are easy-to-use and safe, as well as a more economical way for a couple to address some of these issues. For more information about Rinovum Women's Health, The Stork Ib2C, Inc., and The Stork OTC, visit www.rinovum.com and www.storkotc.com. ### ART-0523 R01 .

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1008-475 Artwork, the Stork OTC Product Information Leaflet, 8.5X11
The Stork® OTC Conception Device Where to Purchase For information on where to purchase, please visit • Available without a prescription our website at www.storkotc.com and click “Shop • Assist conception in the privacy of home Now” for a full list of retailers. You can also purchase direct from our website. • Cost-eﬀective: a cost alternative to more invasive, costly, in-clinic treatments Available online and in-store at select retailers: • Easy to use: 3 simple steps Testimonials Complete Instructions for Use are provided with The Stork OTC device. Please read these carefully prior to use. For a video version of the instructions, please visit our website at: www.storkotc.com. Questions? “My wife and I got married while I was in the Army and between my deployments and careers we ended up waiting until our we were almost Always speak to your Healthcare Professional if you 40 to try to start a family. We both had a lot of concerns about our ability to conceive but fortunately the Stork was available. We were able have any concerns or questions about your fertility to use it in the privacy of our own home and after only two tries, we or health in general. conceived. We’re 6 months along now and we couldn’t be happier!” – A.K.Z., US If you have any questions relating to The Stork OTC, please contact Customer Service at “Thank you!!! After over a year of trying to conceive and ﬁnding out husband had a few sperm related issues, we got pregnant on our second [email protected] or by phone at 1.412.200.7996.
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1 United States District Court Eastern District Of
2:16-cv-11810-MAG-RSW Doc # 10 Filed 06/08/16 Pg 1 of 24 Pg ID 95 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN SOUTHERN DIVISION CONCEIVEX, INC., ) ) Plaintiff, ) ) JURY TRIAL DEMANDED v. ) ) Case No. 16-cv-11810 RINOVUM WOMEN’S HEALTH, ) Hon. Mark A. Goldsmith INC., THE STORK IB2C, INC., ) and RINOVUM WOMEN’S ) HEALTH, LLC, ) ) Defendants. ) FIRST AMENDED COMPLAINT FOR PATENT AND TRADEMARK INFRINGEMENT Plaintiff Conceivex, Inc. (“Conceivex”), for its Complaint against Defendants, alleges as follows: Nature Of Action, Parties, and Jurisdiction 1. This is a civil action for patent infringement under the Patent Laws, 35 U.S.C. 1 et seq., for trademark infringement and false designation of origin under the Lanham Act, 15 U.S.C. §§ 1051 et seq., for deceptive trade practices under Michigan statutory law; and for unfair competition and trademark infringement under Michigan common law. 1 2:16-cv-11810-MAG-RSW Doc # 10 Filed 06/08/16 Pg 2 of 24 Pg ID 96 2. This Court has subject matter jurisdiction of this action under 28 U.S.C. §§ 1331, 1338, and 1367. The matter in controversy exceeds the sum of $75,000, exclusive of interests and costs. 3. Conceivex is a Michigan corporation with its principal place of business at 4111 Andover Road West, Bloomfield Hills, MI 48302. (Conceivex’s former principal place of business was at 5 East Main Street, Saranac, MI 48881.) Conceivex is a leader in assisting couples to overcome difficulties in conceiving. It offers the CONCEPTION KIT at-home fertility system. 4. On information and belief, Defendant Rinovum Women’s Health, Inc.
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The Stork® OTC Expands to More Retailers Nationwide
PRESS RELEASE CONTACT: Brianna Clements 724-241-8936 [email protected] Leslie Swiantek 724-880-1122 [email protected] The Stork® OTC Expands to More Retailers Nationwide The first and only conception assistance device cleared by the FDA for home use without a prescription is now available at select Target stores nationwide PITTSBURGH, Pa., June 13th, 2017– Rinovum Women's Health announced today that The Stork ® OTC – the only FDA-cleared over-the-counter device designed to optimize the chances of at-home conception – is now available for purchase in 1,292 Target stores across the United States. The Stork OTC is also available at major pharmacy chains nationwide. Using the cervical cap insemination technique, The Stork® OTC offers a safe, easy-to- use treatment option for couples trying to build a family naturally in the privacy of their own home. The Stork OTC is a uniquely designed medical device that uses a condom-like sheath to deliver sperm as closely as possible to the cervical opening. The cervical cap insemination technique has up to a 20% success rate. This innovative alternative can be especially helpful for the 7.3 million people in the U.S. experiencing difficulty conceiving due to infertility1. “The Stork OTC is a safe option for couples facing challenges with infertility,” said Stephen Bollinger, Rinovum President and CEO. “It’s an easy-to-use, drug-free, cost- effective way to assist your chances to conceive a child.” This type of treatment has been used effectively in the professional setting, but now it’s readily available to couples at home.
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(12) United States Patent (10) Patent No.: US 8.454.493 B2 La Vean (45) Date of Patent: Jun
USOO8454493B2 (12) United States Patent (10) Patent No.: US 8.454.493 B2 La Vean (45) Date of Patent: Jun. 4, 2013 (54) CONCEPTION DEVICE AND RELATED 3,037,508 A 6, 1962 Friedman METHODS 3,371,664 A 3, 1968 Pleshette 3,952,737 A 4/1976 Lipfert et al. ck (75) Inventor: Michael LaVean, Saranac, MI (US) :33; A t Styal. 128,832 4,200,090 A 4, 1980 Drobish (73) Assignee: Conceivex, Inc., Saranac, MI (US) 4,200,091 A 4, 1980 Del Conte 4,219,016 A 8, 1980 Drobish et al. (*) Notice: Subject to any disclaimer, the term of this 1895; A RE: s h etal patent is extended or adjusted under 35 4,311,543- W I A 1/1982 StrickmanOS et3. al. U.S.C. 154(b) by 306 days. 4,320,751 A 3, 1982 Loeb (21) Appl. No.: 12/815,003 (Continued) 22) Filed Jun. 14, 2010 FOREIGN PATENT DOCUMENTS (22) Filed: un. 14, WO WO99.36O10 7, 1999 O O WO WO 99.37259 7, 1999 (65) Prior Publication Data WO WO 2006/0584.09 8, 2006 Related U.S. Application Data International Search Report and Written Opinion of the International (63) Continuation-in-part of application No. 1 1/692,511, Saching Authority for International Application No. PCT/US2008/ filed on Mar. 28, 2007, now abandoned. 000505: Mailing date Jun. 20, 2008. (Continued) (51) Int. Cl. A6B 7/2425 (2006.01) Primary Examiner — Charles A Marmor, II (52) S.C. 6OO/33 Assistant Examiner — Catherine E Burk ... T. grgrrr.
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Equity Research [email protected]
October 5, 2010 Jason Napodano, CFA 312-265-9421 Equity Research [email protected] www.zacks.com 111 North Canal Street, Chicago, IL 60606 INVO Bioscience (IVOB-OTC) IVOB: INVOcell Launched In Canada UPDATE Through Exclusive Agreement This morning INVO Bio announced its INVOcell device has been launched in Canada through an exclusive distribution agreement with Invaron Pharma. We see this as a significant near-term opportunity for the company. Outperform Current Recommendation The INVOcell device has been elegantly designed to Prior Recommendation N/A provide several advantages when compared to Date of Last Change 05/24/2010 interuterine insemination (IUI) or in vitro fertilization (IVF). These advantages include lower risk of ovarian Current Price (10/05/10) $0.08 hyperstimulation syndrome, lower risk of anesthesia complications, and wider applicability and availability for Target Price $0.25 infertile couples. New reimbursement policies in Canada should help drive uptake of INVOCell over the next several years. SUMMARY DATA 52-Week High $0.51 Risk Level Above Average 52-Week Low $0.03 Type of Stock Small-Growth One-Year Return (%) -83.80 Industry Med-Biomed/Gene Beta -0.96 Zacks Rank in Industry 45 of 138 Average Daily Volume (sh) 121,134 ZACKS ESTIMATES Shares Outstanding (mil) 63 Market Capitalization ($mil) $3 Revenue (in millions of $) Short Interest Ratio (days) N/A Q1 Q2 Q3 Q4 Year Institutional Ownership (%) N/A Insider Ownership (%) N/A (Mar) (Jun) (Sep) (Dec) (Dec) 2009 0.04 A 0.02 A 0.00 A 0.01 A 0.06 A Annual Cash Dividend $0.00 2010 0.02 A 0.01 A 0.02 E 0.02 E 0.07 E Dividend Yield (%) 0.00 2011 0.10 E 2012 0.16 E 5-Yr.
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Muhamad Zulhanif Bin Mat Harun 940610-11-5849 Cm071022
MUHAMAD ZULHANIF BIN MAT HARUN 940610-11-5849 CM071022 What is birth control? 'Birth control' is a term that describes things that stop a woman or girl from becoming pregnant, or giving birth. Birth control can mean a wide range of things ± from 'contraceptives' (used to reduce the chances of a woman becoming pregnant) to other ways of avoiding pregnancy, like not having sex. Contraception Are there many different methods of contraception? Yes. Contraceptives work by preventing a man¶s sperm from fertilising a woman¶s egg, and this can be done in several different ways. There are two main types of contraception: y Barrier methods - which physically prevent sperm from swimming into the uterus and fertilising the woman¶s egg y Hormonal methods - which alter a woman¶s hormonal cycle to prevent fertilisation. These are the main types of contraception that are generally used by teenagers. Condoms for sale in a Chicago pharmacy Other types of contraception, which are generally not used by young people, include natural methods such as only having sex at certain times of the month (these are often not effective enough), and sterilization, which is a permanent surgical procedure. The intrauterine device (IUD) and intrauterine system (IUS), also known as 'the coil', are generally not used by young people although in some countries, such as the UK, they are now considered suitable for all age groups. Barrier methods of contraception There are three main barrier methods of contraception used by teens: the male condom, the female condom, and spermicides in the form of foams or gels.
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Bharathiar University
DEVELOPMENTAL BIOLOGY AND HUMAN WELFARE M.Sc Zoology II YEAR BHARATHIAR UNIVERSITY COIMBATORE – 641046 SCHOOL OF DISTANCE EDUCATION 1 2 DEVELOPMENTAL BIOLOGY AND HUMAN WELFARE TABLE OF CONTENTS UNIT TITLE PAGES I GAMETOGENESIS 4 II FERTILIZATION PROCESS 30 III EMBRYOGENESIS 43 IV EMBRYONIC INDUCTION 73 V HUMAN WELFARE 105 3 UNIT I GAMETOGENESIS Sexual reproduction involves the formation of male and female gametes and the mechanisms necessary for the gametes to come together and fuse to form one cell that represents the beginning of a new individual with a distinct genetic identity. Preparation for pregnancy involves two main programs of events: The process of formation of the male and female gametes occurs in the gonads (ovary or testis). SPERMATOGENESIS 1.0 INTRODUCTION 1.1 STRUCTURE OF THE GERMINAL EPITHELIUM 1.2 DEVELOPMENTAL STAGES OF SPERMATOGENESIS 1.3 THE TEMPORAL COURSE OF SPERMATOGENESIS 1.4 SPERMATOCYTOGENESIS 1.5 LOCAL COURSE OF SPERMATOGENESIS - THE SPERMATOGENESIS WAVE 1.6 SPERMIOGENESIS (SPERMATOHISTOGENESIS) AND STRUCTURE OF THE SPERM CELL 1.7 LEYDIG'S INTERSTITIAL CELLS AND HORMONAL REGULATION 1.0 INTRODUCTION Spermatogenesis is initiated in the male testis with the beginning of puberty. This comprises the entire development of the spermatogonia (former primordial germ cells) up to sperm cells. The gonadal cords that are solid up till then in the juvenile testis develop a lumen with the start of puberty. They then gradually transform themselves into spermatic canals. They are termed convoluted seminiferous tubules (Tubuli seminiferi contorti) and are so numerous and thin that in an adult male testicle. They are coated by a germinal epithelium that exhibits two differing cell populations: some are sustentacular cells (= Sertoli's cells) and the great majority of the germ cells in various division and differentiation.
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The FERTI·LILY Conception Cup Increases the Chance of Conceiving in Comparison with Expected Pregnancy Rates: a Prospective Observational Study
Journal of Pregnancy and Newborncare ISSN: 2688-7487 Research Article The FERTI·LILY Conception Cup Increases the Chance of Conceiving in Comparison with Expected Pregnancy Rates: A Prospective Observational Study This article was published in the following Scient Open Access Journal: Journal of Pregnancy and Newborncare Received 29 March 2021; Accepted 12 April 2021; Published 14 April 2021 1 2 Grada van den Dool , Gonnie van Osta and Abstract Maarten Wiegerinck3* 1Nij Linge, Kinderwenscentrum, Gorinchem, 4207 Background: With the average age of first-time mothers increasing over the last HG, The Netherlands decades in the Western countries, difficulties to conceive naturally are rising in parallel. 2Data Analysis and Medical Writing, Hilversum, The FERTI·LILY Conception Cup (FCC) is a medical device designed to stimulate natural 1213AP, The Netherlands conception. The aim of the current study was to evaluate the safety, efficacy, and user 3Wiegerinck Consultancy, Eindhoven, 5613CJ, The feasibility of the FCC. Netherlands Material and methods: 85 female volunteers trying to conceive entered the prospective, 1-arm, open label, non-randomized, observational study and were followed-up for maximally 3 months. The pregnancy rate observed in the study was compared to the pregnancy expectation based on 2 prognostic models to determine the device’s efficacy. Through questionnaires, information about safety, pregnancy, and user feasibility was collected. Results: Of the 85 study participants, 65 used the product as instructed throughout the study. No Adverse Events (AEs) were reported. 23 participants conceived during the study, resulting in an overall pregnancy rate of 35.4% in the population that completed the study according to protocol, in contrast to the predicted rate of 23.9% (p < 0.05).
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Male and Female Infertility: Causes, and Management
IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) e-ISSN: 2279-0853, p-ISSN: 2279-0861.Volume 18, Issue 9 Ser.13 (September. 2019), PP 27-32 www.iosrjournals.org Male and Female Infertility: Causes, And Management Murtaza Mustafa!, AM,Sharifa2,Janan Hadi3,EM.IIIzam4,,S.Aliya5, 1,3, Faculty of Medicine and Health Sciences, UniversityMalaysia,Sabah,KotaKinabalu,Sabah,Malaysia. 2. Quality Unit Hospital Queen Elizabeth,KotaKinabalu,Sabah,Malaysia 4, Poly Clinic Sihat,Likas,KotaKinabalu,Sabah,Malaysia 5,MedicalCollege,ZiauddinUniversity,Karachi,Pakistan * Corresponding Author:Murtaza Mustafa Abstract:Infertility is a common problem worldwide. Childlessness could be male infertility,femaleinfertility or combined infertility. Infertility has psychological and social impact. Female infertility is due to ovulatory problem, in male semen quality, and idiopathic cause. Sexually transmitted disease (STD), genetic, diabetes, pituitary factors, and toxins also play and importantrole.Diagnosisinclude, semenanalysis, for male, female partner tested for hormonal para meters,e.g.,FSH,TSH, abnormal levels indication of infertility. If the conservative medical treatment fail, physician my advice the patient to undergo in-vitro fertilization(IVF),and assisted reproductive technology (ART).IVF has promising results. Keywords:Infertility,Causes, Psychological and social impact,Treatment. --------------------------------------------------------------------------------------------------------------------------------------- Date of Submission: 12-09-2019
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DRAFT-1008-245 the STORK OTC FAQS Customer
PG.1 Frequently Asked Questions Is there clinical data on the Stork OTC? Can I use The Stork OTC without using the condom? Are there any known complications with or adverse reactions to using the device? A post coital study (peer-reviewed and published in Surgical Technology International XXVII) demonstrates on The Stork OTC can be used without the condom, but should not be used with another condom other than the one There are no publications that discuss whether cap usage can cause TSS (toxic shock syndrome). The Instructions Has the product been evaluated by the FDA? average a 3.23 higher value of sperm concentration at the cervix with the Stork OTC compared to the value of sperm provided. Please read the instructions leaﬂet provided with the device for details on how to use without the condom. for Use instruct the user to remove the cap four to six hours after insertion to reduce the risk of TSS. The risk of Yes, the Stork OTC received FDA over-the-counter clearance in July of 2014 (K140186). The product is available to concentration with natural intercourse, for 85% of study participants. The remaining 15% of subjects saw no change Toxic Shock Syndrome (TSS) exists for products like tampons and other vaginal devices. TSS is a rare but serious purchase without a prescription at multiple retailers. For a full list of retailers visit in sperm concentration between the Stork OTC and natural intercourse. Can I use a regular condom with the applicator provided? disease that may cause death. Warning signs of TSS include sudden fever (usually 102° F or more) and vomiting, http://www.storkotc.com/where-to-buy/ Use only the Conceptacle (the condom-like sheath with the cervical cap inside) provided in the Stork OTC packaging.
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Equity Research [email protected]
November 23, 2010 Jason Napodano, CFA 312-265-9421 Equity Research [email protected] www.zacks.com 111 North Canal Street, Chicago, IL 60606 INVO Bioscience (IVOB-OTC) IVOB: Disappointing Third Quarter, But UPDATE Signs Point To Better Times Ahead INVO Bio reported disappointing third quarter financial results. The company did not record any sales of its INVOcell device during the quarter due to funding issues and assembly delays at the manufacturer. Both issues Outperform Current Recommendation have been worked out and orders placed during the third Prior Recommendation N/A quarter were shipped in mid-October 2010. Although Date of Last Change 05/24/2010 sales of the INVOcell device have been low, the clinical data begin generated by post-approval marketing studies Current Price (11/23/10) $0.06 around the world has been impressive. Data flow should improve over the next several quarters, and thus we Target Price $0.20 believe sales will start to trend higher. Priority number one for management is to secure funding over the near-term for operations and the filing of the U.S. 510(k) application. SUMMARY DATA 52-Week High $0.43 Risk Level Above Average 52-Week Low $0.03 Type of Stock Small-Growth One-Year Return (%) -83.78 Industry Med-Biomed/Gene Beta -0.86 Zacks Rank in Industry 23 of 138 Average Daily Volume (sh) 70,514 ZACKS ESTIMATES Shares Outstanding (mil) 63 Market Capitalization ($mil) $4 Revenue (in millions of $) Short Interest Ratio (days) N/A Q1 Q2 Q3 Q4 Year Institutional Ownership (%) N/A Insider Ownership (%) N/A (Mar) (Jun) (Sep) (Dec) (Dec) 2009 0.04 A 0.02 A 0.00 A 0.01 A 0.06 A Annual Cash Dividend $0.00 2010 0.02 A 0.01 A 0 A 0.02 E 0.05 E Dividend Yield (%) 0.00 2011 0.10 E 2012 0.16 E 5-Yr.
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Artificial Insemination Market Report 2017, Trends, Analysis, Share, Estimates and Forecasts to 2022
Aug 08, 2017 23:34 EDT Artificial Insemination Market Report 2017, Trends, Analysis, Share, Estimates and Forecasts to 2022. According to Stratistics MRC, the Artificial Insemination Market is estimated at $XX million in 2015 and is expected to reach $XX million by 2022 growing at a CAGR of XX% from 2015 to 2022. Changing lifestyle and growing focus of modern women regarding Planned Parenthood due to uninterrupted full time career are some of the key factors anticipated to drive the growth of the global artificial insemination market. Moreover, factors such as cost efficiency in comparison to other fertilization procedures and rising cases of male infertility are the other factors that could boost the market. However, the market is facing some of challenges which include safety issues, ethical concerns, and high risk of transmission of sexual transmitted diseases. Amongst end users, home based segment is expected to grow at a high CAGR after hospital and fertility centers due to availability of various easy to use kits in the market. Asia Pacific holds the largest share in the global market and is expected to grow which can be attributed to increasing disposable income and awareness amongst the population. Some of the key players in this market include Bescot Healthcare, Hi-Tech Solutions, Church & Dwight Co. Inc., Conceivex Inc, Rinovum Women's Health LLC (US), TenderNeeds Fertility, Pride Angel, Clearblue, Insemination Supplies, LLC, The Stork Ib2C, Inc., Kate & Duck and Boots Pharmaceuticals. For More, Please Visit: http://www.strategymrc.com/report/artificial-
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